Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01674621
Other study ID # BA058-05-007
Secondary ID 2012-001921-29
Status Completed
Phase Phase 2
First received
Last updated
Start date September 25, 2012
Est. completion date August 2, 2013

Study information

Verified date May 2020
Source Radius Health, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when compared to transdermal placebo and abaloparatide injection for 6 months of treatment.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date August 2, 2013
Est. primary completion date August 2, 2013
Accepts healthy volunteers No
Gender Female
Age group N/A to 85 Years
Eligibility Inclusion Criteria:

- Postmenopausal woman, less than 85 years old.

- BMD T-score =-2.5 of spine or hip (femoral neck) or =-2.0 with previous fracture (within 5 years).

- Normal physical exam, vital signs, electrocardiogram (ECG), and medical history.

- Laboratory tests within the normal range, including serum calcium, Vitamin D, parathyroid hormone (PTH) (1-84), serum phosphorus, and alkaline phosphatase.

Exclusion Criteria:

- BMD T-score =-5.0 at the lumbar spine or hip.

- History of bone disorders (for example, Paget's disease) other than postmenopausal osteoporosis.

- Significantly impaired renal function.

- History of any cancer.

Study Design


Intervention

Drug:
Abaloparatide Transdermal (50 mcg)
Abaloparatide Transdermal Microneedle Active Patch
Abaloparatide Transdermal (100 mcg)
Abaloparatide Transdermal Microneedle Active Patch
Abaloparatide Transdermal (150 mcg)
Abaloparatide Transdermal Microneedle Active Patch
Abaloparatide Injection (80 mcg)
Abaloparatide Subcutaneous Injection
Abaloparatide Placebo
Abaloparatide Transdermal Microneedle Placebo Patch

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Radius Health, Inc. Nordic Bioscience A/S

Countries where clinical trial is conducted

United States,  Denmark,  Estonia,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine. Baseline, 6 Months
Secondary Percent Change From Baseline in BMD of Total Hip at 6 Months Percent change in BMD as specified by DXA scans of the total hip. Baseline, 6 Months
Secondary Percent Change From Baseline in BMD of Forearm at 6 Months Percent change in BMD as specified by DXA scans of the forearm. Baseline, 6 Months
Secondary Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months Baseline, 6 Months
Secondary Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months Baseline, 6 Months
Secondary Percent Change From Baseline in Serum Osteocalcin at 6 Months Baseline, 6 Months
Secondary Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months Baseline, 6 Months
Secondary Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months Baseline, 6 Months
Secondary Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) A full physical examination included, at a minimum: general appearance, skin, head/ears/eyes/nose/throat, lungs/chest, breasts, heart, abdomen, lymph nodes, musculoskeletal, extremities, and neurologic. Physical examination results that were considered abnormal were determined by the Investigator. A summary of other non-serious adverse events (AEs) and all serious AEs (SAEs), regardless of causality is located in Reported AE section. Baseline up to 6 Months
Secondary Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes Vital sign parameters included respiration rate (breaths/minute), body temperature (°C), systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg), and heart rate (bpm). Number of participants for each TEAE is presented. The same participant may be included in more than one TEAE category. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline up to 7 Months
Secondary Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result The following ECG parameters were recorded: rhythm, heart rate, PR interval, QRS duration and QT/QTc. ECG results that were considered clinically meaningful were to be determined by the Investigator. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline up to 7 Months
Secondary Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4 Hematology laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: white blood cell (Grade 3: 1.0-1.9*10^9/liter [L]; Grade 4 <1.0*10^9/L), platelets (Grade 3: 25.0-49.9*10^9/L; Grade 4: <25.0*10^9/L), haemoglobin (Grade 3: 65.0-79.0 grams [g]/L or 4.0-4.9 mmol/L; Grade 4: <65.0 g/L or <4.0 millimole [mmol]/L), granulocytes/bands (Grade 3: 0.5-0.9*10^9/L; Grade 4: <0.5*10^9/L), lymphocytes (Grade 3: 0.5-0.9*10^9/L; Grade 4: <0.5 *10^9/L), haemorrhage (Grade 3: gross, 3 - 4 units transfusion per episode; Grade 4: massive, > 4 units transfusion per episode). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline up to 6 Months
Secondary Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 Chemistry laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: sodium, potassium, chloride, inorganic phosphorus, albumin, total protein (Grade 3: 4 (+), >1.0 g%, or >10 g/L; Grade 4: nephrotic syndrome), glucose, blood urea nitrogen (BUN), creatinine (Grade 3: 3.1-6.0*normal; Grade 4: >6.0*normal), uric acid, aspartate aminotransferase (AST) (Grade 3: 5.1-20.0 units [U]/L*normal, Grade 4: >20.0 U/L*normal), alanine aminotransferase (ALT) (Grade 3: 5.1-20.0 U/L*normal; Grade 4: >20.0 U/L*normal), gamma-glutamyltranspeptidase (GGT), creatine phosphokinase (CPK), alkaline phosphatase (Grade 3: 5.1-20.0 U/L*normal; Grade 4: >20.0 U/L*normal), total bilirubin (Grade 3: 1.5-3.0*normal; Grade 4: >3.0*normal), lactate dehydrogenase (LDH), cholesterol, triglycerides, total calcium. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline up to 6 Months
Secondary Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 Coagulation laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: prothrombin time (quick) (Grade 3: 1.51%-2.00%*normal, Grade 4: >2.00%*normal), partial thromboplastin time (Grade 3: 2.34-3.00 seconds [sec], Grade 4: >3.00 secs*normal). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline up to 6 Months
See also
  Status Clinical Trial Phase
Completed NCT01732770 - Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Phase 4
Completed NCT00377234 - A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis. Phase 4
Recruiting NCT05571514 - Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis N/A
Completed NCT00048074 - DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Phase 3
Completed NCT02347865 - Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France
Completed NCT00545480 - SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis. Phase 4
Completed NCT00303485 - A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate) Phase 4
Active, not recruiting NCT05332626 - Lactobacillus Acidophilus and Postmenopausal Osteoporosis Women N/A
Completed NCT00545090 - ExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis. Phase 4
Completed NCT02598934 - A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis Phase 4
Completed NCT01290094 - A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis Phase 3
Completed NCT00048061 - MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis Phase 3