Study Evaluating Changes in Bone Mineral Density (BMD), and Safety of rhBMP-2/CPM in Subjects With Decreased BMD. - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00752557

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, Multicenter, Randomized, Active-Controlled, Parallel-Group, Dose Finding and Safety Study of rhBMP-2/CPM in Subjects With Decreased Bone Mineral Density

Resource links provided by NLM:

MedlinePlus related topics: Calcium Minerals Osteoporosis

Drug Information available for: Calcium gluconate Vitamin D

U.S. FDA Resources

Further study details as provided by Wyeth:

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. A safety review team consisting of health care professionals is responsible for reviewing the safety information from the trial. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	240
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental rhBMP-2/CPM , 1.0 mg/mL	Drug: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
2: Experimental rhBMP-2/CPM , 2.0 mg/mL	Drug: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
3: Active Comparator Oral bisphosphonate therapy (standard of care)	Drug: bisphosphonates, calcium, and vitamin D Oral bisphosphonate therapy

Eligibility

Ages Eligible for Study:	65 Years and older
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

1.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). 2.Coagulopathy and/or history of venous thromboembolic events (deep vein thrombosis, pulmonary embolus, retinal vein thrombosis) within the past 12 months. 3.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

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

Locations

United States, Florida

New Port Richey, Florida, United States, 34652

Ft. Lauderdale, Florida, United States, 33316
United States, Missouri

St. Louis, Missouri, United States, 63110
United States, Nebraska

Omaha, Nebraska, United States, 68131
United States, New York

New York, New York, United States, 10032
United States, North Carolina

Durham, North Carolina, United States, 27705
United States, Tennessee

Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3100N0-2213
Study First Received:	September 12, 2008
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00752557 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Bone mineral density,
bone morphogenetic protein,
osteoporosis

Study placed in the following topic categories:

Ergocalciferol
Ergocalciferols
Osteoporosis
Bone Diseases, Metabolic
Bone Density Conservation Agents
Trace Elements
Bone Diseases
Signs and Symptoms

Calcium, Dietary
Vitamin D
Diphosphonates
Vitamin D2
Musculoskeletal Diseases
Vitamins
Calciferol
Micronutrients

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Ergocalciferols
Osteoporosis
Bone Diseases, Metabolic
Bone Density Conservation Agents
Bone Diseases

Pharmacologic Actions
Diphosphonates
Vitamin D
Musculoskeletal Diseases
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on September 02, 2009