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Sponsored by: |
Radius Health |
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Information provided by: | Radius Health |
ClinicalTrials.gov Identifier: | NCT00542425 |
The purpose of this study is to determine whether BA058, a modified version of the natural hormone PTHrP (parathyroid hormone-related peptide) which is important in bone formation, is effective in building bone in postmenopausal women with osteoporosis and to choose the optimal dose to bring forward into Phase 3 development.
Condition | Intervention | Phase |
---|---|---|
Osteoporosis |
Drug: BA058 Drug: PTH Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Parallel-Group, Phase 2 Dose-Finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis |
Estimated Enrollment: | 225 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator |
Drug: Placebo
0 ug subcutaneous Daily for 6 months
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2: Experimental |
Drug: BA058
20 ug, 40 ug, or 80 ug subcutaneous Daily for 6 months
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3: Experimental |
Drug: BA058
20 ug, 40 ug, or 80 ug subcutaneous Daily for 6 months
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4: Experimental |
Drug: BA058
20 ug, 40 ug, or 80 ug subcutaneous Daily for 6 months
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5: Active Comparator |
Drug: PTH
20 ug subcutaneous Daily for 6 months
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Many of the drugs prescribed for osteoporosis work by preventing further bone loss. Parathyroid hormone (PTH) and parathyroid hormone-related peptide (PTHrP) have both been shown to promote bone growth in humans when given in an intermittent manner. This study will evaluate the ability of BA058, a modified version of the natural hormone PTHrP, to promote bone growth in postmenopausal women with osteoporosis.
The study encompasses 24 weeks of treatment. Participants will be randomly assigned to receive BA058, a placebo, or an approved PTH medication by subcutaneous injection, one time per day. There will be 13 study visits, including a screening visit, two pretreatment visits, nine treatment visits, and a follow-up visit. Participants will be asked to take a Calcium and Vitamin D supplement throughout the study. Medical history, a physical exam, vital signs, ECGs, blood and urine collections, and scans to measure bone density will occur at selected visits.
Ages Eligible for Study: | 55 Years to 85 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Primary Inclusion Criteria:
Primary Exclusion Criteria:
United States, Massachusetts | |
Radius Health, Inc. | |
Cambridge, Massachusetts, United States, 02139 |
Study Director: | Louis St.L. O'Dea, MB BCh BAO. FRCP(C) | Radius Health, Inc. |
Responsible Party: | Radius Health, Inc. ( Jonathan Guerriero, Program Director ) |
Study ID Numbers: | BA058-05-002 |
Study First Received: | October 10, 2007 |
Last Updated: | March 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00542425 |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; India: Ministry of Health |
osteoporosis postmenopausal bone loss |
Signs and Symptoms Musculoskeletal Diseases Osteoporosis Bone Diseases, Metabolic Bone Diseases |