Cyclic Versus Daily Teriparatide on Bone Mass

• Status: Unknown status
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: Female

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 continuous versus cyclic treatment with teriparatide combined with alendronate, another drug for osteoporosis, or teriparatide alone in women with osteoporosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Helen Hayes Hospital
• Collaborators: Health Research, Inc.; National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Alendronate; Calcium; Calcium, Dietary; Cholecalciferol; Ergocalciferols; Teriparatide; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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