Research

A Randomized, Controlled, Double-Blind Study of the Early Effects of Teriparatide versus Placebo on the Proximal Femur

IRB Number: 10001

Institutional Review Board, Hospital for Special Surgery

July 27, 2010

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Mathias P. Bostrom, M.D.

Co-Investigators

Felicia Cosman, MD, Helen Hayes Hospital
David W. Dempster, PhD, Helen Hayes Hospital
Robert Lindsay, MD, Helen Hayes Hospital
Jeri W. Nieves, PhD Helen Hayes Hospital.
Cathy Roimisher, NP Helen Hayes Hospital and Hospital for Special Surgery

Summary

Teriparatide (Forteo) is a potent osteoporosis medication that helps prevent fractures. However, we know little about its effect on the hip. The purpose of this study is to determine what changes Teriparatide has on hip structure and how it might help reduce hip fracture risk. We will evaluate hip bone samples from patients that we will be treating with either teriparatide (Forteo) or a placebo (an inactive substance) for 6 weeks before their surgical hip replacement. The overall participation in this study will be over a period of 10 weeks. A total of 60 subjects (men and women) will participate in this study at HSS and HHH. Study participation will involve a total of 3 study visits. Most visits are expected to last 30-60 minutes, except the last visit, which is the date of surgical hip replacement.

Inclusion/Exclusion Criteria

Inclusion Criteria

 Age 60-85
 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 by Dr Bostrom.

Exclusion Criteria

 Any contraindications to use of TPTD
 Age younger than 60, greater than 85.
 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 0 deficiency or renal disease
 Active hyperthyroidism or excessive thyroid hormone replacement (with TSH below normal range)
 Moderately severe renal impairment (serum creatinine>2.0 mg/L or estimated GFR <30 ml/min)
 Severe vitamin D deficiency (250HD level <10 ng/ml)
 History of multiple renal calculi or renal calculus within 2 years
 Long term prior use of tetracyclines or contraindication to use (allergy)
 Diagnosis of joint or other rheumatologic disease other than osteoarthritis (including rheumatoid arthritis, lupus, psoriatic arthritis, inflammatory bowel disease or mixed connective tissue disease)
 Use of oral or intravenous glucocorticoids or high dose inhaled steroids for ~4 weeks within the last 3 months
 Recent (less than 5 years) diagnosis of cancer (other than basal or squamous cell of the skin)

Contact Information

Cathy Roimisher, Research Nurse
845.786.4757



Request an Appointment