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NCT00752557 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Pfizer.

Completed
Registry status
Phase 2
Development phase
50
Enrollment target

NCT00752557: Completed Phase 2 study, sponsored by Pfizer.

NCT00752557 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00752557, a Phase 2 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target

Study 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.

Primary Outcome

Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure. BMD is defined as a derived measure of bone density, generated by dividing the bone mineral content value obtained from a bone densitometry technique (for example, DXA) by the t

Interventions

  • DRUG rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
  • DRUG bisphosphonates, calcium, and vitamin D

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2008-12-03
Est. Completion 2015-04-24
Phase Phase 2
Pfizer

1,845 total trials

What the finished NCT00752557 record still lists

NCT00752557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 2 interventions - of which rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy) is the first listed.

NCT00752557 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00752557 about?

NCT00752557 is a clinical study titled "Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD". 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 ...

What is the current status of trial NCT00752557?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2008-12-03. Estimated completion is 2015-04-24.

What interventions are being tested in trial NCT00752557?

The interventions under investigation include: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy) (DRUG), bisphosphonates, calcium, and vitamin D (DRUG).

Who is sponsoring clinical trial NCT00752557?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00752557's enrollment target sits among peer trials

50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00752557, the US trial registry maintained by the National Library of Medicine. NCT00752557 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.