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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 March 15, 2019

FOR MORE INFORMATION
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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Pfizer Clinical Trials Contact Center

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[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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