Early Effects of Parathyroid Hormone (PTH) on the Proximal Femur
Early Effects of PTH on the Proximal Femur
2 other identifiers
interventional
40
1 country
1
Brief Summary
Teriparatide is a potent osteoporosis medication that helps prevent fractures, however, the investigators know little about its effect on the hip. The investigators will evaluate hip bone samples from patients treated with teriparatide before undergoing hip replacement. The information will help us understand how teriparatide might help reduce hip fracture risk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 4, 2011
CompletedFirst Posted
Study publicly available on registry
March 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedNovember 23, 2016
November 1, 2016
4.3 years
March 4, 2011
November 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone formation rate
At the time of surgery, the femoral neck and a small piece of bone will be obtained and measured for indices of bone formation in the femur and iliac crest in both placebo or teriparatide groups.
6 weeks
Secondary Outcomes (1)
Blood samples will be analyzed for indices of bone formation (serum P1NP) and resorption (serum CTX) after treatment with placebo or teriparatide Biochemical markers of bone
six weeks
Study Arms (2)
teriparatide
ACTIVE COMPARATORsix weeks of teriparatide
placebo
PLACEBO COMPARATORplacebo identical in appearance to teriparatide
Interventions
Eligibility Criteria
You may qualify if:
- Age 50-90 years old.
- Male or postmenopausal (women who have had no menses for one year)
- Degenerative joint disease of the hip (osteoarthritis) requiring total hip arthroplasty, based on radiologic and clinical impression.
You may not qualify if:
- Any contraindications to use of TPTD.
- Age younger than 50, greater than 90 years old.
- Metabolic bone disease other than osteoporosis.
- History of hyperparathyroidism without surgical correction.
- Unexplained hypercalcemia.
- Paget's disease (or unexplained elevated bone alkaline phosphatase level).
- History of any metastatic cancer or osteosarcoma.
- Prior radiation treatment.
- Secondary hyperparathyroidism due to vitamin D deficiency or renal disease. Active hyperthyroidism or excessive thyroid hormone replacement (with TSH below normal range).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Helen Hayes Hospital
West Haverstraw, New York, 10993, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felicia Cosman, M.D.
Helen Hayes Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director, Clinical Research Center, Helen Hayes Hospital
Study Record Dates
First Submitted
March 4, 2011
First Posted
March 7, 2011
Study Start
August 1, 2010
Primary Completion
November 1, 2014
Study Completion
August 1, 2015
Last Updated
November 23, 2016
Record last verified: 2016-11