Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy); rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy); bisphosphonates, calcium, and vitamin D
Intervention description: Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 1.0 mg/mL.; Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 2.0 mg/mL.; Oral bisphosphonate therapy
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Ergocalciferols; Cholecalciferol; Diphosphonates; Vitamins; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: Female
Minimum age: 65 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Bone mineral density; bone morphogenetic protein; osteoporosis

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.