Text Size

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

This study is currently recruiting participants.
Verified March 2011 by Health Research, Inc.
Sponsor:
Collaborator:
Hospital for Special Surgery, New York
Information provided by:
Health Research, Inc.
ClinicalTrials.gov Identifier:
NCT01309399
First received: March 4, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Early Effects of PTH on the Proximal Femur

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Further study details as provided by Health Research, Inc.:

Primary Outcome Measures:
  • 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.


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 ] [ 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


Estimated Enrollment: 60
Study Start Date: August 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • Age 60-85 years old.
  • Male or postmenopausal (women who have had no menses for one year) female BMD T-Score at the Spine (at least 2 evaluable vertebrae), Total Hip, Femoral Neck or Trochanter between -1.5 and -3.0.
  • 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 60, greater than 85 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309399

Locations
United States, New York
Helen Hayes Hospital Recruiting
West Haverstraw, New York, United States, 10993
Contact: Cathy Roimisher, NP     845-786-4757     roimisherc@helenhayeshosp.org    
Principal Investigator: Felicia Cosman, MD            
Sponsors and Collaborators
Health Research, Inc.
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Felicia Cosman, M.D. Helen Hayes Hospital
  More Information

No publications provided

Responsible Party: Felicia Cosman, M.D.
ClinicalTrials.gov Identifier: NCT01309399     History of Changes
Other Study ID Numbers: 09-09, RO1 AR059204-01
Study First Received: March 4, 2011
Last Updated: March 4, 2011
Health Authority: United States: Helen Hayes Hospital Institutional Review Board

Keywords provided by Health Research, Inc.:
bone formation rate
total hip arthroplasty

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

ClinicalTrials.gov processed this record on May 19, 2013