Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover

PHASE4RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 21, 2022

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Age-Related Osteoporosis
Interventions
DRUG

Teriparatide

Participants will receive 20 μg teriparatide per day via subcutaneous injections. Participants, and if needed a caregiver, will be trained in the subcutaneous administration of teriparatide according to the manufacturer's guidelines. The investigators will measure serum calcium, BSAP and TRAP-5b levels via blood draws at quarterly monitoring visits. If BSAP or TRAP-5b do not increase compared to baseline or decrease after any quarter, participants will be contacted and correct administration will be reviewed. Serum calcium is measured for safety to avoid hypo- and hypercalcemia. Participants will also be given a daily dose of Vitamin D of 800 IUs to prevent development of Vitamin D deficiency.

DRUG

Alendronate

Participants will receive 70 mg alendronate p.o. once per week. Participants will be carefully instructed to follow the manufacturer's recommendations for administration. Compliance will be assessed by measurement of the bone turnover markers BSAP and TRAP-5b from blood drawn at quarterly monitoring visits. These markers have been shown to be useful for assessment of turnover changes with treatment. If these markers do not decrease compared to baseline or rise after any quarter, participants will be contacted and correct administration will be reviewed. Participants will also be given a daily dose of Vitamin D of 800 IUs to prevent development of Vitamin D deficiency.

Trial Locations (1)

40536

RECRUITING

University of Kentucky, Lexington

All Listed Sponsors
collaborator

National Institute on Aging (NIA)

NIH

lead

Madhumathi Rao

OTHER