Phase 2
Completed N=222
Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis
Source: ClinicalTrials.gov NCT00542425 ↗Enrolled (actual)
222
Serious AEs
2.3%
Results posted
Jul 2010
Primary outcomePrimary: Change in Marker of Bone Metabolism, PINP — -13.1; 20.0; 90.8; 97.2 Percent change from baseline — p=<0.001
Summary
The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Marker of Bone Metabolism, PINP |
-13.1; 20.0; 90.8; 97.2; 154.3 | <0.001 sig |
| PRIMARY Change in Bone Mineral Density, Total Spine. |
0.74; 5.14; 9.84; 12.94; 8.63 | — |
| SECONDARY Change in Bone Mineral Density, Femoral Neck. |
0.79; 2.69; 2.20; 3.07; 1.07 | — |
| SECONDARY Change in Bone Mineral Density, Total Hip. |
0.39; 1.43; 1.97; 2.60; 0.45 | — |
| SECONDARY Change in Bone Mineral Density, Total Spine. |
0.74; 5.14; 9.84; 12.94; 8.63 | — |
Eligibility Criteria
Primary Inclusion Criteria:
- The patient has a bone mineral density T-score ≤ 2.5 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA). Women with a bone mineral density T-score of 2.0 or lower and a prior low-trauma forearm, humerus, vertebral, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years, or who have an additional risk factor such as age 65 or greater or a strong maternal history of osteoporosis defined as a fracture related to osteoporosis or osteoporosis itself as determined by BMD criteria, are also study candidates.
- The patient is in good general health as determined by medical history and physical examination and is without evidence of clinically significant abnormality in the opinion of the Investigator.
Primary Exclusion Criteria:
- History of bone disorders (e.g., Paget's disease) other than postmenopausal osteoporosis.
- Prior treatment with approved or as yet unapproved bone-acting investigational agents.
- History of carcinoma, nephrolithiasis or urolithiasis within the past five years or osteosarcoma at any time.
- History of radiotherapy (radiation therapy).
Data sourced from ClinicalTrials.gov (NCT00542425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.