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NCT01753856 · ClinicalTrials.gov registry record · Phase 4
Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis
A Phase 4 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 69
- Enrollment target
NCT01753856: Completed Phase 4 study, sponsored by Eli Lilly and Company.
NCT01753856 is a Phase 4 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 69 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01753856, a Phase 4 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 69 participants
- Enrollment target
Study Summary
The purpose of this study is to determine how teriparatide or denosumab affects the bone of postmenopausal women with osteoporosis after 3 months of treatment, as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis).
Primary Outcome
MS /BS is a measure of the proportion of BS on which new mineralized bone is deposited at the time of DEM or TET labeling, and calculated as the sum of the total extent of double label (DL) plus half the extent of single label (SL) divided by BS. At baseline (18 days prior to randomization / study drug administration), DEM was administered (3 days on, 12 days off, 3 days on). 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered (sam
Interventions
- DRUG Denosumab
- DRUG Tetracycline
- DRUG Teriparatide
- DRUG Calcium Supplement
- DRUG Demeclocycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-06 |
| Phase | Phase 4 |
What the finished NCT01753856 record still lists
NCT01753856 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 5 interventions - of which Denosumab is the first listed.
NCT01753856 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01753856 about?
NCT01753856 is a clinical study titled "Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis". The purpose of this study is to determine how teriparatide or denosumab affects the bone of postmenopausal women with osteoporosis after 3 months of treatment, as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis).
What is the current status of trial NCT01753856?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 69 participants. The study started on 2013-01. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01753856?
The interventions under investigation include: Denosumab (DRUG), Tetracycline (DRUG), Teriparatide (DRUG), Calcium Supplement (DRUG), Demeclocycline (DRUG).
Who is sponsoring clinical trial NCT01753856?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01753856's enrollment target sits among peer trials
69 1070th of 2000 higher than 925 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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