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Trial record 1 of 1 for:    NCT00752557
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Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD

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ClinicalTrials.gov Identifier: NCT00752557
Recruitment Status : Completed
First Posted : September 15, 2008
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 12, 2008
First Posted Date  ICMJE September 15, 2008
Last Update Posted Date June 16, 2015
Study Start Date  ICMJE December 2008
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2008)
Changes in Bone Mineral Density will be measured by dual-energy x-ray absorptiometry [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00752557 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2013)
  • Safety of injecting rhBMP-2/CPM, measured by physical exams and other tests such as radiographs and electrocardiograms. [ Time Frame: 36 months ]
  • Feasibility of administering rhBMP-2/CPM as a minimally invasive technique in an outpatient (ambulatory care) setting. [ Time Frame: Dosing ]
  • Evaluate long-term changes in BMD after injection of rhBMP-2/CPM. [ Time Frame: 36 Months ]
  • Evaluate bone quality with emphasis on cortical thickness and trabecular volume in region(s) of interest, utilizing quantitative computed tomography. [ Time Frame: 24 Months ]
  • Evaluate changes in biochemical markers of bone turnover to identify markers that are predictive of changes in BMD from baseline. [ Time Frame: 12 Months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis
Intervention  ICMJE
  • 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.
  • 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.
  • Drug: bisphosphonates, calcium, and vitamin D
    Oral bisphosphonate therapy
Study Arms  ICMJE
  • Experimental: 1
    rhBMP-2/CPM , 1.0 mg/mL
    Intervention: Drug: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
  • Experimental: 2
    rhBMP-2/CPM , 2.0 mg/mL
    Intervention: Drug: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
  • Active Comparator: 3
    Oral bisphosphonate therapy (standard of care)
    Intervention: Drug: bisphosphonates, calcium, and vitamin D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2015)
50
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2008)
240
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Poland,   Spain,   United States
Removed Location Countries Canada,   Netherlands
 
Administrative Information
NCT Number  ICMJE NCT00752557
Other Study ID Numbers  ICMJE 3100N0-2213
B1921002 ( Other Identifier: Alias Study Number )
2007-007456-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP