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Early Effects of Parathyroid Hormone (PTH) on the Proximal Femur

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01309399
First Posted: March 7, 2011
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hospital for Special Surgery, New York
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Felicia Cosman, M.D., Health Research, Inc.
  Purpose
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.

Condition Intervention
Osteoporosis Drug: Teriparatide Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Early Effects of PTH on the Proximal Femur

Resource links provided by NLM:


Further study details as provided by Felicia Cosman, M.D., Health Research, Inc.:

Primary Outcome Measures:
  • Bone formation rate [ Time Frame: 6 weeks ]
    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.


Secondary Outcome Measures:
  • 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 [ Time Frame: six weeks ]
    Blood samples will be analyzed for indices of bone formation (serum P1NP) and resorption (serum CTX) after treatment with placebo or teriparatide


Enrollment: 40
Study Start Date: August 2010
Study Completion Date: August 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: teriparatide
six weeks of teriparatide
Drug: Teriparatide
six weeks of teriparatide
Other Name: forteo
Placebo Comparator: placebo
placebo identical in appearance to teriparatide
Other: placebo
placebo

Detailed Description:

Osteoporosis with consequent hip fractures causes substantial disability, morbidity and mortality. Teriparatide (TPTD), the aminoterminal fragment of parathyroid hormone (PTH), increases bone mineral density (BMD) and bone strength and reduces fracture incidence throughout the skeleton, but data confirming specific efficacy against hip fracture will never be available. Histomorphometric studies after 18-36 months of TPTD treatment show improvements in bone volume and structure in the iliac crest. Both biochemical and histomorphometric investigations of the iliac crest at very early time points (within 4-6 weeks of administration) show that bone formation is dramatically stimulated. Apart from the beneficial effect of TPTD on bone density and bone strength by finite element analysis at the hip, nothing is known about the mechanism of the effect of TPTD on the proximal femur. While BMD changes are smaller and slower in the hip in response to TPTD than in the spine, it is possible that stimulation of bone formation on the periosteal bone surface could result in expansion of bone size, obscuring the increase in non-invasively measured BMD. The current study will provide evidence for or against this possible TPTD-induced periosteal expansion. From a clinical perspective, it is unclear whether TPTD would be preferable to other osteoporosis medications, such as zoledronic acid, in patients at high risk for hip fracture. TPTD induced bone formation in the femur would be expected to improve bone strength and would provide a mechanistic basis for the use of TPTD in patients at high risk of hip fracture. The proposed project is the only practical and ethical way to obtain information on the effects of TPTD on bone formation in the proximal femur in humans. In patients undergoing total hip arthroplasty (THA) for degenerative joint disease, the hip samples of greatest interest are extracted routinely during the procedure. At the same time, an iliac crest biopsy can be taken with minimal added time and risk. The protocol has the following Specific Aims:

In patients undergoing elective, noncemented total hip arthroplasty (THA): 1. To determine the early effects of 1-34hPTH (teriparatide; TPTD 20 mcg) vs placebo, administered subcutaneously daily for 6 weeks, on histomorphometric indices of bone formation in cancellous and cortical bone of the proximal femur (femoral neck and intertrochanteric bone) and iliac crest. 2. To evaluate the association between changes in biochemical indices of bone turnover and histomorphometric indices of bone formation in the proximal femur (femoral neck and intertrochanteric bone) and iliac crest over 6 weeks of treatment with TPTD vs. placebo. 3. To determine if circulating osteoblast precursor cells increase over 6 weeks of treatment with TPTD vs Placebo and to compare the change in size of this osteoblast precursor pool with the change in a biochemical marker of bone formation and indices of bone formation in the femur and iliac crest.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01309399


Locations
United States, New York
Helen Hayes Hospital
West Haverstraw, New York, United States, 10993
Sponsors and Collaborators
Health Research, Inc.
Hospital for Special Surgery, New York
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Felicia Cosman, M.D. Helen Hayes Hospital
  More Information

Responsible Party: Felicia Cosman, M.D., Medical Director, Clinical Research Center, Helen Hayes Hospital, Health Research, Inc.
ClinicalTrials.gov Identifier: NCT01309399     History of Changes
Other Study ID Numbers: 09-09
R01AR059204-01 ( U.S. NIH Grant/Contract )
First Submitted: March 4, 2011
First Posted: March 7, 2011
Last Update Posted: October 19, 2017
Last Verified: November 2016

Keywords provided by Felicia Cosman, M.D., Health Research, Inc.:
bone formation rate
total hip arthroplasty

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs