Status:
UNKNOWN
Cyclic Versus Daily Teriparatide on Bone Mass
Lead Sponsor:
Helen Hayes Hospital
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Health Research, Inc.
Conditions:
Osteoporosis
Eligibility:
FEMALE
45-85 years
Phase:
PHASE2
Brief Summary
Osteoporosis is a disease that affects millions of individuals in the United States and abroad. It leads to decreased bone mass and causes an increased risk of fracture. This study will compare contin...
Detailed Description
Osteoporosis is a serious bone disease that has become an important public health problem. It causes significant loss of bone mass and increases the risk of both fracture and architectural problems wi...
Eligibility Criteria
Inclusion
- Diagnosis of osteoporosis or T score below -2 plus one or more osteoporosis related fractures
- Two measurable vertebrae between L1 and L4
- Willing to undergo a single iliac crest biopsy after administration of 4 tetracycline labels
Exclusion
- Secondary causes of osteoporosis or presence of a skeletal disorder other than osteoporosis
- Uses drugs likely to affect skeletal or calcium homeostasis
- Multiple vertebral fractures or severe degenerative changes with fewer than two evaluable vertebrae
- Unwilling to undergo a single iliac crest biopsy
- History of allergy to tetracyclines, exposure to tetracyclines within the last year, or any remote long term use of tetracyclines
- Current use of anti-resorptive medicines (other than alendronate for half the female participants)
- Use of hormone therapy, estrogen therapy, raloxifene, or calcitonin within 6 months before study entry
- Use of any bisphosphonate for more than 3 months within 2 years before study entry (only applies to participants in Groups 4, 5, and 6)
- History of a kidney stone within 5 years before study entry or any history of multiple kidney stones
- Hypercalcemia, hypercalciuria, or elevated parathyroid hormone (reduced 25-hydroxyvitamin D will be corrected prior to admission)
- Esophageal ulceration or stricture or known hypersensitivity to bisphosphonates
- History of external radiation therapy
- Unlikely or unable to complete the study, as determined by the investigators
- Illicit drug use or excessive alcohol consumption
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2017
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00668941
Start Date
September 1 2005
End Date
November 1 2017
Last Update
August 10 2017
Active Locations (1)
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1
Helen Hayes Hospital
West Haverstraw, New York, United States, 10993