Phase 2
N=50
Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00752557 ↗Enrolled (actual)
50
Serious AEs
37.0%
Results posted
Mar 2020
Primary outcome: Primary: Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) — -0.0026; 0.1299; 0.1196; -0.0029 gram per centimeter squared (g/cm^2)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy) (Drug); bisphosphonates, calcium, and vitamin D (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- Female
- Sponsor
- Pfizer
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) |
-0.0026; 0.1299; 0.1196; -0.0029; 0.1063; 0.1192 | — |
| PRIMARY Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip |
136.8; 165.6; 151.6; 45.1; 77.8; 88.4 | — |
| PRIMARY Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck |
144.3; 166.3; 164.4; 61.1; 165.0; 159.3 | — |
| SECONDARY Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC) |
2.5782; 2.4259; 2.5128; 0; 4.7073; 4.2205 | — |
| SECONDARY Number Participant Responses to Injectability Questionnaire Injected Population |
15; 14; 0; 0; 15; 11 | — |
| SECONDARY Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline |
0; 0; 0 | — |
| SECONDARY Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip |
0.73; 0.71; 0.71 | — |
Summary
The main purpose of this study is to assess whether a locally-administered rhBMP-2/CPM injection can rapidly increase bone mass in subjects at high risk for osteoporotic fractures of the hip. All subjects will receive standard treatment for low bone mass, consisting of bisphosphonates, calcium, and vitamin D (all taken by mouth). Subjects that are randomly selected to receive treatment with rhBMP-2 will receive an injection directly into the hip. The injection is given in a surgery room using a light anesthesia.
Eligibility Criteria
Inclusion Criteria
- Community-dwelling, ambulatory (with or without assistive device), postmenopausal females, age greater than 65 years.
- BMD T-score (total hip or femoral neck) of -2.5 or less in at least 1 hip. Subjects with BMD T-scores of -2.0 or less may be enrolled if at least one of the following risk factors is also present:
- Age greater than 75 years
- Family (maternal) history of fragility fracture
- Previous fragility fracture (self) after age 45
- Subjects may either be treatment naïve or on a previously-established regimen ( greater than 1year, but less than 5 years duration) of bisphosphonate therapy. Subjects must be willing to comply with 1of the 3 protocol-designated oral bisphosphonates (risedronate, alendronate, or ibandronate sodium) with risedronate considered as first-line therapy.
Exclusion Criteria
- Metabolic bone disorder or disease affecting bone and mineral metabolism (eg, Paget's disease, vitamin D deficiency [ less than 20 ng/mL], hyperparathyroidism, renal osteodystrophy, osteomalacia, hypocalcemia, hypercalcemia).
- Coagulopathy and/or history of venous thromboembolic events (deep vein thrombosis, pulmonary embolus, retinal vein thrombosis) within the past 12 months.
- Inflammatory arthritis including rheumatoid, psoriatic, or crystal-induced (gouty) arthritis, or those associated with systemic lupus erythematosus (SLE), spondyloarthropathy, Reiters syndrome, or Crohns disease.
Data sourced from ClinicalTrials.gov (NCT00752557). 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.