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Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00752557
First received: September 12, 2008
Last updated: June 15, 2015
Last verified: June 2015
  Purpose
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.

Condition Intervention Phase
Osteoporosis
Drug: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
Drug: bisphosphonates, calcium, and vitamin D
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Active-controlled, Parallel-group, Dose-finding And Safety Study Of Recombinant Human Bone Morphogenetic Protein-2 (Rhbmp-2)/Calcium Phosphate Matrix (Cpm) In Subjects With Decreased Bone Mineral Density

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Changes in Bone Mineral Density will be measured by dual-energy x-ray absorptiometry [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of injecting rhBMP-2/CPM, measured by physical exams and other tests such as radiographs and electrocardiograms. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Feasibility of administering rhBMP-2/CPM as a minimally invasive technique in an outpatient (ambulatory care) setting. [ Time Frame: Dosing ] [ Designated as safety issue: Yes ]
  • Evaluate long-term changes in BMD after injection of rhBMP-2/CPM. [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • Evaluate bone quality with emphasis on cortical thickness and trabecular volume in region(s) of interest, utilizing quantitative computed tomography. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Evaluate changes in biochemical markers of bone turnover to identify markers that are predictive of changes in BMD from baseline. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: December 2008
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
rhBMP-2/CPM , 1.0 mg/mL
Drug: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 1.0 mg/mL.
Experimental: 2
rhBMP-2/CPM , 2.0 mg/mL
Drug: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 2.0 mg/mL.
Active Comparator: 3
Oral bisphosphonate therapy (standard of care)
Drug: bisphosphonates, calcium, and vitamin D
Oral bisphosphonate therapy

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752557

  Show 35 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00752557     History of Changes
Other Study ID Numbers: 3100N0-2213  B1921002  2007-007456-34 
Study First Received: September 12, 2008
Last Updated: June 15, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Bone mineral density
bone morphogenetic protein
osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Diphosphonates
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 23, 2016