Status:
COMPLETED
Heartland Osteoporosis Prevention Study
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
Creighton University Medical Center
Conditions:
Osteopenia
Eligibility:
FEMALE
19+ years
Phase:
PHASE3
Brief 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 vita...
Detailed Description
This randomized controlled trial (RCT) will compare changes after 12 months in bone structure, bone mineral density (BMD), and bone turnover in women with low bone mass who are within 5 years of menop...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT02186600
Start Date
February 1 2015
End Date
June 1 2019
Last Update
October 5 2023
Active Locations (1)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198