A Study of Monthly Risedronate for Osteoporosis

Postmenopausal Osteoporosis Clinical Trial

Official title:

A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247273
• Other study ID #: 2005032
• Secondary ID: EFC6062 AND HMRF
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2005
• Last updated: April 15, 2013
• Start date: October 2005
• Est. completion date: April 2008

Study information

• Verified date: April 2013
• Source: Warner Chilcott
• 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 trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

Description:

The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1294
• Est. completion date: April 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Female: 50 years of age or older

• >5 years since last menses natural or surgical

• have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture

Exclusion Criteria:

• history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia

• BMI (body mass index) >32 kg/m^2

• use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone

• hypocalcemia or hypercalcemia of any cause

• markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• risedronate
tablet, 5 mg risedronate, once a day for 2 years
• risedronate
oral, 150 mg risedronate, once a month for 2 years

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Capital Federal
Australia	Research Site	Geelong
Australia	Research Site	Heidelberg, Victoria
Australia	Research Site	Saint Leonards
Belgium	Research Site	Brussels
Belgium	Research Site	Gent
Belgium	Research Site	Leuven
Belgium	Research Site	Liege
Belgium	Research Site	Mont Godinne
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Sao Paulo
Canada	Research Site	Calgary
Canada	Research Site	Montreal
Canada	Research Site	Sainte Foy
Canada	Research Site	Saskatoon
Estonia	Research Site	Parnu
Estonia	Research Site	Tartu
Finland	Research Site	Helsinki
Finland	Research Site	Kuopio
Finland	Research Site	Oulu
Finland	Research Site	Turku
France	Research Site	Amiens Cedex 1
France	Research Site	Lyon Cedex
France	Research Site	Orleans
France	Research Site	Paris
France	Research Site	Toulouse
France	Research Site	Vandoeuvre Les Nancy
Hungary	Research Site	Balatonfured
Hungary	Research Site	Budapest
Hungary	Research Site	Gyor
Hungary	Research Site	Miskolc
Hungary	Research Site	Nagykanizs
Lebanon	Research Site	Beirut
Norway	Research Site	Oslo
Norway	Research Site	Paradis
Norway	Research Site	Trondheim
Poland	Research Site	Bialystok
Poland	Research Site	Warszawa
Spain	Research Site	Barcelona
Spain	Research Site	Granada
Spain	Research Site	Madrid
United States	Research Site	Bethesda	Maryland
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Gainesville	Georgia
United States	Research Site	Lakewood	Colorado
United States	Research Site	Omaha	Nebraska
United States	Research Site	Portland	Oregon
United States	Research Site	West Haverstraw	New York

Sponsors (2)

Lead Sponsor	Collaborator
Warner Chilcott	Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Estonia,  Finland,  France,  Hungary,  Lebanon,  Norway,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population	BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).	Baseline to Month 12 - Endpoint	No
Secondary	Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population	BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.	Baseline to Month 12	No
Secondary	Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population	BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.	Baseline to Month 12	No
Secondary	Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)	BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 24).	Baseline to Month 24 - Endpoint	No
Secondary	Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population	BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.	Baseline to Month 24	No
Secondary	Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population	BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.	Baseline to Month 24	No
Secondary	Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population	Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. nmol BCE / mmol Creatinine = nanomoles bone collagen equivalents / millimoles Creatinine	Baseline to Month 6	No
Secondary	Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population	Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.	Baseline to Month 6	No
Secondary	Change From Baseline in Urine NTX/Cr at Month 24, ITT Population	Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.	Baseline to Month 24	No
Secondary	Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population	Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.	Baseline to Month 24	No
Secondary	Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population	ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay.	Baseline to Month 6	No
Secondary	Percent Change From Baseline in Serum CTX at Month 6, ITT Population	Assayed by electrochemiluminescent immunoassay.	Baseline to Month 6	No
Secondary	Change From Baseline in Serum CTX at Month 24, ITT Population	Assayed by electrochemiluminescent immunoassay.	Baseline to Month 24	No
Secondary	Percent Change From Baseline in Serum CTX at Month 24, ITT Population	Assayed by electrochemiluminescent immunoassay.	Baseline to Month 24	No
Secondary	Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population	ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay)	Baseline to Month 6	No
Secondary	Percent Change From Baseline in Serum BAP at Month 6, ITT Population	Assayed by ELISA (enzyme-linked immunosorbent assay)	Baseline to Month 6	No
Secondary	Change From Baseline in Serum BAP at Month 24, ITT Population	Assayed by ELISA (enzyme-linked immunosorbent assay)	Baseline to Month 24	No
Secondary	Percent Change From Baseline in Serum BAP at Month 24, ITT Population	Assayed by ELISA (enzyme-linked immunosorbent assay)	Baseline to Month 24	No
Secondary	Number of Participants With New Vertebral Fracture at Month 12, ITT Population	At least 1 new fractured vertebra	Baseline to Month 12	No
Secondary	Number of Participants With New Vertebral Fracture at Month 24, ITT Population	At least 1 new fractured vertebra	Baseline to Month 24	No