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Bisphosphonate

Exercise for Osteopenia (HOPS Trial)

Phase 3
Waitlist Available
Led By Nancy L Waltman, PhD, APRN-NP
Research Sponsored by Nancy L. Waltman, BSN MSN PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6, 12 months
Awards & highlights

HOPS Trial 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.

Eligible Conditions
  • Osteopenia

HOPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Bone Strength Index of the Distal Tibia Based on Randomization to Control, Risedronate, or Exercise Group.
Secondary outcome measures
Change in Bone Mineral Density (BMD) at the Spine (L1-L4) Based on Randomization to Control, Risedronate, or Exercise Group.
Change in Serum Measures of Bone Resorption (Serum NTx) Based on Randomization to Control, Risedronate, or Exercise Group.

HOPS Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: RisedronateExperimental Treatment3 Interventions
Subjects in the risedronate group will take 35 mg of the bisphosphonate "risedronate" weekly for 12 months plus CaD. They will be asked to follow the protocol for administration of risedronate including taking the medication upon arising in the morning with an 8 ounce glass of water, remaining upright for at least 30 minutes, and having no oral intake except water for at least 30 minutes.
Group II: ExerciseExperimental Treatment3 Interventions
Subjects in the exercise group will participate in bone-loading exercises three times weekly in addition to taking CaD for 12 months. Women will exercise at community Young Men's Christian Association's fitness centers (YMCA) and exercises will be monitored by on-site Exercise Trainers. Exercises will consist of high-impact weight-bearing exercises (jogging with weighted vests) and resistance exercises for upper and lower extremities. Progressive increases in weight loads will be prescribed to provide maximal strength gains.
Group III: ControlActive Control2 Interventions
Women randomized to the control group will receive calcium and vitamin D intake for 12 months. Calcium intake will be determined by analyzing 3 day dietary intake of calcium at baseline and then prescribing calcium carbonate supplements to ensure women have ~1200 mg of calcium daily. Vitamin D intake will be determined using baseline measures of Serum 25 (OH) D. Subjects who have serum D levels of 30 ng/ml or greater will be prescribed 1,000 IU vitamin D3 daily; subjects with levels of 20-29 ng/ml will be prescribed 2,000 IU Vitamin D3; and subjects with levels of 10-19 ng/ml will be prescribed 3,000 IU Vitamin D3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Calcium carbonate
FDA approved
Cholecalciferol
FDA approved
Risedronic acid
FDA approved
Bone-loading exercises
2015
Completed Phase 3
~280

Find a Location

Who is running the clinical trial?

Nancy L. Waltman, BSN MSN PhDLead Sponsor
University of NebraskaLead Sponsor
539 Previous Clinical Trials
1,144,458 Total Patients Enrolled
Creighton University Medical CenterOTHER
4 Previous Clinical Trials
616 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Medicine & Science in Sports & ExerciseJournal
Quantity and Quality of Exercise for Developing and Maintaining Cardiorespiratory, Musculoskeletal, and Neuromotor Fitness in Apparently Healthy Adults
Garber, Carol Ewing, Bryan Blissmer, Michael R. Deschenes, Barry A. Franklin, Michael J. Lamonte, I-Min Lee, David C. Nieman, and David P. Swain. 2011. “Quantity and Quality of Exercise for Developing and Maintaining Cardiorespiratory, Musculoskeletal, and Neuromotor Fitness in Apparently Healthy Adults”. Medicine & Science in Sports & Exercise. Ovid Technologies (Wolters Kluwer Health). doi:10.1249/mss.0b013e318213fefb.
clinicaltrials.govStudy
Heartland Osteoporosis Prevention Study
Nancy L. Waltman, BSN MSN PhD 2015. "Heartland Osteoporosis Prevention Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02186600.
~27 spots leftby Apr 2025
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