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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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NCT00752557

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Arizona Research Center, Inc.
Phoenix, Arizona, 85023 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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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Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Osteoporosis
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 2015
April 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
65 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Poland,   Spain,   United States
Canada,   Netherlands
 
NCT00752557
3100N0-2213
B1921002 ( Other Identifier: Alias Study Number )
2007-007456-34 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2015

ICMJE     Data element required by the

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

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