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Heartland Osteoporosis Prevention Study

NCT02186600 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2023-10-05

Study results available
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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.

Conditions

  • Osteopenia

Interventions

DRUG

Calcium Carbonate

Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)

DRUG

Vitamin D3

Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.

DRUG

Risedronate

Risedronate 35 mg orally will be ingested weekly by subjects in Risedronate group.

BEHAVIORAL

Bone-loading exercises

Subjects will participate in bone loading exercises (weight-bearing and resistance) three times weekly at community YMCAs.

Sponsors & Collaborators

  • Creighton University Medical Center

    collaborator OTHER

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Nancy L Waltman, PhD, APRN-NP · University of Nebraska

  • Laura Bilek, PT, PhD · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-01
Primary Completion
2019-06-01
Completion
2019-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02186600 on ClinicalTrials.gov