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

Last updated on November 7, 2019

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Study Location
Arizona Research Center, Inc.
Phoenix, Arizona, 85023 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoporosis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00752557
Pfizer
Completed
Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD

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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 SummaryThe 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 DescriptionNot 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 DateApril 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 CountriesCanada,   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 CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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