Heartland Osteoporosis Prevention Study

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to identify the best way to prevent bone loss in the first years after menopause. The HOPS study will compare bone loss at 12 months in women: 1) who take calcium and vitamin D only; 2) who take calcium and vitamin D plus the medication "risedronate"; or 3) who take calcium and vitamin D plus participate in bone-loading exercises. Our central hypothesis is that improvements in bone health will be greater in women randomized to bone-loading exercises with calcium and vitamin D compared to women who take calcium and vitamin D only or women who take calcium and vitamin D plus risedronate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nancy L. Waltman, BSN MSN PhD
• Collaborators: Creighton University Medical Center; University of Nebraska
• Treatments: Calcium; Calcium Carbonate; Calcium, Dietary; Cholecalciferol; Ergocalciferols; Etidronic Acid; Risedronate Sodium; Risedronic Acid; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Women who are in their first 5 years of menopause

• Have a T score between -1 and -2.49 at the femoral neck, total hip, or L1-L4 spine

• Be 19 years of age or older

• Have their health care provider's permission to enroll in the study.

Exclusion Criteria:

• Have osteoporosis

• Have a 10 yr probability of hip fracture >3% or major fracture >20% based on results of the fracture risk assessment (FRAX) tool

• Currently take bisphosphonates, estrogen replacement therapy, glucocorticosteroids, or other drugs affecting bone

• Currently participate in a resistance training or high impact weight bearing exercise program three or more times weekly

• Weigh >300 lbs

• Have abnormal results for the following laboratory tests: serum 25(OH)D; serum creatinine; serum calcium; parathyroid hormone (PTH); thyroid stimulating hormone (TSH).

• Have Paget's disease, heart disease, uncontrolled hypertension, renal disease, or other concomitant conditions that prohibit participation in exercises, risedronate therapy, or use of CaD supplements.