Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1

HIV-1 Clinical Trial

— MODERN  

Official title:

A Multicenter, Randomized, Double‑Blind, Comparative Trial Of Maraviroc + Darunavir/Ritonavir Versus Emtricitabine/Tenofovir + Darunavir/Ritonavir For The Treatment Of Antiretroviral‑Naive Hiv‑Infected Patients With Ccr5‑Tropic Hiv‑1

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01345630
• Other study ID #: A4001095
• Secondary ID: 2010-021785-30
• Status: Terminated
• Phase: Phase 3
• First received: April 27, 2011
• Last updated: December 11, 2015
• Start date: September 2011
• Est. completion date: January 2014

Study information

• Verified date: December 2015
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.

Description:

The study was terminated on October 8, 2013 following a preliminary review of the Week 48 primary efficacy data by the study's external independent Data Monitoring Committee (DMC). The DMC assessed the data as demonstrating significant differences between the treatment arms in virologic responses and failures. The DMC recommended and the Sponsor concurred that the study be terminated because of the inferior efficacy of the Maraviroc arm as compared to the comparator arm (Emtricitabine/Tenofovir).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 813
• Est. completion date: January 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Plasma HIV-1 RNA equal to or greater than 1,000 copies/mL measured at the Screening Visit.

• CD4 count equal to or greater than 100 cells/mm3 at Screening.

• Have only R5 HIV 1 at Screening as verified by a randomized tropism assay.

Exclusion Criteria:

• Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.

• Any evidence of genotypic/phenotypic resistance to darunavir, tenofovir, and emtricitabine.

• CXCR4 using virus detected using randomized tropism determination or repeated failure to obtain an interpretable tropism result.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV-1

Intervention

Drug:
• Maraviroc
Maraviroc tablet 150 mg once daily for 96 weeks.
• Emtricitabine/tenofovir
Emtricitabine/tenofovir tablet 200/300 mg once daily for 96 weeks.
• darunavir/ritonavir 800/100 mg
darunavir/ritonavir 800/100 mg
• placebo for emtricitabine/tenofovir
placebo for emtricitabine/tenofovir
• placebo for maraviroc
placebo for maraviroc

Locations

Country	Name	City	State
Australia	Brisbane Sexual Health and HIV Service	Brisbane	Queensland
Australia	Melbourne Sexual Health Centre	Carlton	Victoria
Australia	East Sydney Doctors	Darlinghurst	New South Wales
Australia	Holdsworth House General Practice	Darlinghurst	New South Wales
Australia	St Vincent's Hospital	Darlinghurst	New South Wales
Australia	Clinical Research Unit, Infectious Diseases	Melbourne	Victoria
Australia	Taylor Square Private Clinic	Surry Hills	New South Wales
Austria	AKH Wien Universitaetsklinik fuer Dermatologie	Wien
Belgium	Instituut voor Tropische Geneeskunde	Antwerpen
Belgium	C.H.U. St-Pierre	Brussels
Belgium	Cliniques Universitaires St-Luc	Brussels
Belgium	Hôpital Universitaire Erasme	Bruxelles
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	C.H.U. Sart-Tilman	Liege
Canada	Clinique Medicale du Quartier Latin	Montreal	Quebec
Canada	Clinique Medicale L'Actuel	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	The Ottawa Hospital-Riverside Campus	Ottawa	Ontario
Canada	Maple Leaf Research / Maple Leaf Medical Clinic	Toronto	Ontario
Canada	University Health Network / Toronto General Hospital	Toronto	Ontario
Canada	Vancouver ID Research and Care Centre Society	Vancouver	British Columbia
Denmark	Hvidovre Hospital, Infektionsmedicinsk afd.	Hvidovre
Denmark	Rigshospitalet, Epidemiklinikken	Koebenhavn OE
Denmark	Odense Universitetshospital	Odense
Finland	Infektiosairauksien poliklinikka,HUS Auroran sairaala, rakennus 5, 1. krs	Helsinki
France	Hopital Saint-andre	Bordeaux cedex
France	Hopital Henri Mondor	Creteil
France	Hopital Bicetre	Le Kremlin Bicetre
France	Hopital de la Croix Rousse	LYON Cedex 4
France	Hopital Gui de Chauliac	Montpellier
France	CHU de Nantes - Hotel Dieu	Nantes
France	CHR d'Orleans la Source	Orleans	Cedex 02
France	Hopital Bichat	Paris	Cedex 18
France	Hôpital de la Pitié Salpétrière	Paris
France	Hopital Saint Antoine	Paris	Cedex 12
France	Hopital Tenon, Service des Maladies Infectieuses	Paris
France	Hopital Saint-Louis	Paris Cedex 10
France	Nouvel Hopital Civil	Strasbourg Cedex
France	Centre Hospitalier de Tourcoing	Tourcoing
Germany	EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH	Berlin
Germany	Praxis Christiane Cordes	Berlin
Germany	Studiengesellschaft mbH Gubener 37	Berlin
Germany	Universitaetsklinikum Bonn, Immunologische Ambulanz HIV	Bonn
Germany	InfektioResearch GmbH & Co. KG	Frankfurt am Main
Germany	Klinikum der J.W. Goethe-Universitaet, Medizinische Klinik II	Frankfurt am Main
Germany	ICH - Study - Center GmbH & Co. KG	Hamburg
Germany	ifi - Studien und Projekte GmbH	Hamburg
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin	Koeln
Germany	Ludwig-Maximilians-Universitaet, Medizinische Poliklinik - Klinikum Innenstadt	Muenchen
Germany	MUC Research Group GbR	Muenchen
Hungary	Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet	Budapest
Italy	Ospedale San Raffaele	Milano
Netherlands	University Medical Center Utrecht	Utrecht
Poland	Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza	Bydgoszcz
Poland	SPZOZ Wojewodzki Szpital Zakazny	Warszawa
Poland	EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej	Wroclaw
Portugal	Hospital Prof. Doutor Fernando Fonseca E.P.E.	Amadora
Portugal	Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos	Lisboa
Portugal	Hospital Sta. Maria	Lisboa
Portugal	Hospital São João	Porto
Puerto Rico	Innovative Care PSC	Bayamon
Puerto Rico	Ararat Research Center	Ponce
Puerto Rico	Medical Center University Hospital	Rio Piedras
Puerto Rico	University of Puerto Rico Medical Sciences Campus	Rio Piedras
Puerto Rico	Clinical Research Puerto Rico	San Juan
Puerto Rico	HOPE Clinical Research	San Juan
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Clinic I Provincial de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Reina Sofia - Hospital Provincial	Cordoba
Spain	Hospital Universitari de Bellvitge	L´hospitalet de Llobregat	Barcelona
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario de La Paz	Madrid
Spain	Hospital Universitario Virgen de la Macarena	Sevilla
Sweden	SU Ostra sjukhuset, Infektionsmottagningen	Goteborg
Sweden	Skanes Universitetssjukhus	Malmo
Sweden	Karolinska Universitetssjukhuset Huddinge	Stockholm
Sweden	Sodersjukhuset, Venhalsan	Stockholm
Switzerland	Universitaetsspital Basel Infektiologie und Spitalhygiene	Basel
Switzerland	Inselspital Universitaetsklinik fuer Infektiologie	Bern
Switzerland	Kantonsspital St. Gallen	St. Gallen
Switzerland	Universitatsspital Zurich	Zurich
United Kingdom	Dept of Sexual Health & HIV Medicine	Birmingham
United Kingdom	HIV Research Department, Elton John Centre	Brighton
United Kingdom	Regional Infectious Diseases Unit	Edinburgh
United Kingdom	Centre for Sexual Health & HIV Research, University College London	London
United Kingdom	Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital,	London
United Kingdom	Ian Charleson Day Centre, Royal Free Hospital	London
United Kingdom	Queen Elizabeth Hospital	London
United Kingdom	St Stephen's Centre, Chelsea and Westminster Hospital NHS Foundation Trust	London
United Kingdom	Department of Infectious Diseases & Tropical Medicine, Pennine Acute Trust Hospitals	Manchester
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	University of Colorado Denver - University of Colorado Hospital	Aurora	Colorado
United States	Central Texas Clinical Research	Austin	Texas
United States	Be Well Medical Center, PC	Berkley	Michigan
United States	University of Alabama at Birmingham - 1917 Research Clinic	Birmingham	Alabama
United States	Erie County Medical Center	Buffalo	New York
United States	I.D. Consultants, P.A.	Charlotte	North Carolina
United States	Howard Brown Health Center	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	Northwestern University/NMH	Chicago	Illinois
United States	University of Cincinnati - Department of Internal Medicine	Cincinnati	Ohio
United States	Dallas Diabetes and Endocrine Center	Dallas	Texas
United States	North Texas Infectious Diseases Consultants, PA	Dallas	Texas
United States	Parkland Memorial Hospital	Dallas	Texas
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	DeKalb Medical Diagnostic Breast Center	Decatur	Georgia
United States	Infectious Disease Specialists of Atlanta	Decatur	Georgia
United States	Kaiser Permanente of Colorado	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	University Physicians Group	Detroit	Michigan
United States	Wayne State University	Detroit	Michigan
United States	Biomedical and Health Institutional Review Board	East Lansing	Michigan
United States	Michigan State University College of Osteopathic Medicine - Department of Internal Medicine	East Lansing	Michigan
United States	Broward General Medical Center	Fort Lauderdale	Florida
United States	Broward Health - Comprehensive Care Center	Fort Lauderdale	Florida
United States	(DEXA Scan Facility) East Carolina University Brody Outpatient Center	Greenville	North Carolina
United States	East Carolina University Division of Infectious Diseases	Greenville	North Carolina
United States	Kaiser Permanente	Hayward	California
United States	Health Services Center	Hobson City	Alabama
United States	Research Access Network	Houston	Texas
United States	The Office of Dr. Gordon E. Crofoot, M.D., PA	Houston	Texas
United States	Therapeutic Concepts, PA	Houston	Texas
United States	University of Iowa, University of Hospitals and Clinics - Division of Infectious Disease	Iowa City	Iowa
United States	Kansas City Free Health Clinic	Kansas City	Missouri
United States	Ingham County Health Department	Lansing	Michigan
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Dr. Anthony Mills, MD, Inc.	Los Angeles	California
United States	Community AIDS Resource Inc dba Care Resource	Miami	Florida
United States	Miami Research Associates	Miami	Florida
United States	The Kinder Medical Group	Miami	Florida
United States	UMHC/Sylvester Comprehensive Cancer Center	Miami	Florida
United States	University of Miami	Miami	Florida
United States	University of Miami AIDS Clinical Research Unit	Miami	Florida
United States	Wohlfeiler, Piperato and Associates, LLC	Miami Beach	Florida
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Brandywine Common	Neptune	New Jersey
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Yale - New Haven Hospital Nathan Smith Clinic	New Haven	Connecticut
United States	Yale University	New Haven	Connecticut
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	AIDS Community Research Initiative of America (ACRIA)	New York	New York
United States	Beth Israel Medical Center - AIDS Clinical Trials Unit	New York	New York
United States	Dr. Howard A. Grossman, M.D.	New York	New York
United States	Research Across America	New York	New York
United States	Saint Michael's Medical Center	Newark	New Jersey
United States	Orange Coast Medical Group	Newport Beach	California
United States	Circle CARE Center	Norwalk	Connecticut
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Desert Oasis Healthcare Medical Group	Palm Springs	California
United States	Infectious Diseases Associates of Northwest Florida, PA	Pensacola	Florida
United States	AIDS Care	Rochester	New York
United States	Kaiser Hospital Sacramento	Sacramento	California
United States	TICON I Research Clinic (DEXA Scan only)	Sacramento	California
United States	University of California Davis Research	Sacramento	California
United States	Investigational Drugs Pharmacy	San Francisco	California
United States	Kaiser Permanente - Clinical Trials Unit	San Francisco	California
United States	Synarc Inc.	San Francisco	California
United States	Kaiser Permanente Santa Clara	Santa Clara	California
United States	Swedish Medical Center	Seattle	Washington
United States	Swedish Medical Center	Seattle	Washington
United States	Baystate Infectious Diseases Clinical Research	Springfield	Massachusetts
United States	Infectious Disease Research Institute, Inc.	Tampa	Florida
United States	Osteoporosis Care Center	Tampa	Florida
United States	Quest Diagnostic Laboratory	Tampa	Florida
United States	St. Joseph's Hospital Diagnostic Center	Tampa	Florida
United States	University of South Florida Health-HIV Clinical Research Unit	Tampa	Florida
United States	The University of Toledo Medical Center	Toledo	Ohio
United States	Kaiser Permanente	Union City	California
United States	New York Medical College	Valhalla	New York
United States	Capital Medical Associates, PC	Washington	District of Columbia
United States	George Washington University Medical Faculty Associates	Washington	District of Columbia
United States	Rowan Tree Medical, PA	Wilton Manors	Florida

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  Finland,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Portugal,  Puerto Rico,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL.	The proportion of participants who achieved HIV-1 RNA <50 copies/mL at week 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm used the plasma HIV-1 RNA in the Week 48 visit window, followed the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.	Week 48	No
Secondary	Frequency of Adverse Events (AE).	Number of participants with treatment-emergent non serious AEs	Week 96	Yes
Secondary	Number of Participants With Grade 3 or 4 AEs	Number of participants with grade 3 or 4 AEs are presented here.	Week 96	Yes
Secondary	Number of Participants Who Discontinued Due to AEs	Number of participants who discontinued due to AEs are reported here. Three participants (two from the MVC+DRV/r arm and one from the FTC/TDF+DRV/r arm) were not considered as discontinued due to AE because other reasons for discontinuation were prioritized for these participants.	Week 96	Yes
Secondary	Number of Treatment-related AEs	Number of treatment-related AEs are presented here.	Week 96	Yes
Secondary	Number of Participants With Treatment-emergent Serious Adverse Events	Total number of participants with treatment-emergent serious adverse events are reported	Week 96	Yes
Secondary	Number of Participants With Abnormal Laboratory Values	Number of participants with laboratory abnormalities are reported	Week 96	Yes
Secondary	Severity of Abnormal Laboratory Values	Number of participants who had clinically significant laboratory abnormalities of Grade 3 and Grade 4 according to DAIDS. Abnormality incidence of highest grade was reported for a labcode for each individual participant.	Week 96	Yes
Secondary	The Relationship Between the Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL at the Week 48 and the Screening Tropism Test (Genotype Test or ESTA).	The relationship of the proportion of participants achieving HIV-1 RNA <50 copies/mL at Week 48 with the screening tropism test for the MVC containing regimen was analyzed. Virologic response for a participant at Week 48 was derived using the FDA's Snapshot MSDF algorithm. Difference in proportions of patients with plasma HIV-1 RNA <50 copies/mL at week 48 between the maraviroc and the emtricitabine/tenofovir treatment arms, with two-sided 95% confidence interval, among patients who are R5 by genotype (including some who were originally randomized to ESTA and are R5 by genotype upon retesting), were calculated via the Maximum Likelihood method. The estimate was adjusted for the screening plasma HIV RNA level (<100,000 vs. =100,000) copies/mL via the Mantel Haenszel (MH) method.	Week 48	No
Secondary	Virologic Outcomes at Week 48 Using Protocol-Defined Treatment Failure (PDTF).	Per the protocol participants who meet the following criteria were regarded as PDTFs requiring a confirmatory plasma HIV-1 RNA determination: • Decrease in plasma HIV-1 RNA <1 log10 from baseline after Week 4 unless plasma HIV-1 RNA is <50 copies/mL, or • Plasma HIV-1 RNA >1.0 log10 above the nadir value after Week 4 where the nadir is the lowest plasma HIV-1 RNA concentration, or • Plasma HIV-1 RNA =50 copies/mL at any time after Week 24, or • Plasma HIV-1 RNA =50 copies/mL after suppression to <50 copies/mL on two consecutive visits, or • Decrease in plasma HIV-1 RNA =2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <400 copies/mL. Decrease in plasma HIV-1 RNA =2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <50 copies/mL (before August 30 2012) or <400 copies/mL (after August 30 2012).	Week 48	No
Secondary	Tropism Change Between Screening or Baseline and PDTF	For participants meeting the PDTF criteria, tropism was assessed using the original randomized and alternate assays (ie, both genotype testing and ESTA). Data reported here corresponds to the timepoint at or after PDTF.	Week 48	No
Secondary	Number of Participants With Viral Resistance to Maraviroc (Maraviroc Treated Participants Only) in Participants Meeting PDTF Criteria.	For participants meeting the PDTF criteria, viral resistance to maraviroc for maraviroc treated participants was assessed in patients with R5 virus at failure. The resistance level is calculated by reference to a laboratory strain of virus that is analyzed in parallel with the clinical isolate to identify 50% inhibitory concentrations (IC50). The maximal percent inhibition is the percent inhibition that is achieved in a titration of the drug at high concentrations when the addition of more drug does not result in increased inhibition. Maximal percent inhibition is obtained in the same way as the titration for IC50, but the key measure is of the plateau height of percent inhibition, where increased concentration of maraviroc does not result in additional inhibition. This is consistent with the virus developing some ability to use maraviroc-bound CCR5 for entry. A significant change in IC50 is not required for this mechanism.	Week 48	No
Secondary	Number of Participants With Resistance to Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTI), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI), and Protease Inhibitors (PI) in Participants Meeting PDTF Criteria	For participants meeting the PDTF criteria, viral resistance (both genotypic and phenotypic) to NRTI, NNRTI, and PI's were assessed at Baseline and on-treatment. The assessment was performed using the overall (i.e. net) susceptibility score provided using the PhenoSense GT assay. The number of participants with successful assessments were 15/17 for the MVC+DRV/r arm and 3/3 for the FTC/TDF+DRV/r arm.	Week 48	No
Secondary	Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 4 (CD4, Cell/mm^3)	The differences in the magnitude of changes in CD4+ at Baseline and at Week 48 for maraviroc versus emtricitabine/tenofovir were compared.	Baseline, Week 48	No
Secondary	Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4 (%)	The differences in the magnitude of changes in CD4+ from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.	Baseline, Week 48	No
Secondary	Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 8 (CD8, Cell/mm^3)	The differences in the magnitude of changes in CD8+ cell counts from baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.	Baseline, Week 48	No
Secondary	Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8 (%)	The differences in the magnitude of changes in CD8+ cell counts from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.	Baseline, Week 48	No
Secondary	Absolute Change in CD4+/CD8+ Ratio From Baseline to Week 48	The differences in the magnitude of changes in CD4+/CD8+ ratio from Baseline through Weeks 48 for maraviroc versus emtricitabine/tenofovir were compared.	Baseline, Week 48	No
Secondary	Changes in Peripheral Fat Distribution Using Dual Energy X-ray Absorptiometry [DEXA] Scan From Baseline and at Week 48.	A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline.	Week 48	Yes
Secondary	Changes in Trunk to Limb Fat Distribution Using DEXA Scan From Baseline and at Week 48	A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline.	Week 48	Yes
Secondary	Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Total Hip BMD	Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4), left total hip and femoral neck as measured by the DEXA scan.	Week 48	Yes
Secondary	Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Femoral Neck BMD	Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from Baseline bone mineral density femoral neck as measured by the DEXA scan.	Week 48	Yes
Secondary	Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - AP Lumbar Spine (L1 - L4) BMD	Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4) as measured by the DEXA scan.	Week 48	Yes
Secondary	Change in Bone Turnover Markers From Baseline and at Week 48 - Blood Osteocalcin	Bone turnover marker, osteocalcin, was collected in the subset of participants participating in the DEXA scan sub-study.	Week 48	Yes
Secondary	Change in Bone Turnover Markers From Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1)	Bone turnover marker, C-telopeptide of type 1 collagen (CTx), was collected in the subset of participants participating in the DEXA scan sub-study.	Week 48	Yes

External Links

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