Overview

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.