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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Health Research, Inc.
Sponsor:
Collaborator:
Hospital for Special Surgery, New York
Information provided by (Responsible Party):
Felicia Cosman, M.D., Health Research, Inc.
ClinicalTrials.gov Identifier:
NCT01309399
First received: March 4, 2011
Last updated: February 26, 2014
Last verified: February 2014

March 4, 2011
February 26, 2014
August 2010
April 2014   (final data collection date for primary outcome measure)
Bone formation rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01309399 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Blood samples will be analyzed for indices of bone formation (serum P1NP) and resorption (serum CTX) after treatment with placebo or teriparatide
Same as current
Not Provided
Not Provided
 
Early Effects of Parathyroid Hormone (PTH) on the Proximal Femur
Early Effects of PTH on the Proximal Femur

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Osteoporosis
  • Drug: Teriparatide
    six weeks of teriparatide
    Other Name: forteo
  • Other: placebo
    placebo
  • Active Comparator: teriparatide
    six weeks of teriparatide
    Intervention: Drug: Teriparatide
  • Placebo Comparator: placebo
    placebo identical in appearance to teriparatide
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
April 2014
April 2014   (final data collection date for primary outcome measure)
  • 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).
Both
50 Years to 90 Years
Yes
United States
 
NCT01309399
09-09, RO1 AR059204-01
Not Provided
Felicia Cosman, M.D., Health Research, Inc.
Health Research, Inc.
Hospital for Special Surgery, New York
Principal Investigator: Felicia Cosman, M.D. Helen Hayes Hospital
Health Research, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP