Heartland Osteoporosis Prevention Study

NCT02186600 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 0378-14-FB
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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 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

Keywords

Low bone mass; Post-menopausal women; Bone mineral density; Bone structure; Bone turnover; Bone-loading exercises; calcium and vitamin D; risedronate

Outcome Measures

Primary Outcomes (1)

• Change in Bone Strength Index of the Distal Tibia Based on Randomization to Control, Risedronate, or Exercise Group.

  Change in Bone Strength Index (BSI) of the distal tibia based on randomization to Control, Risedronate, or Exercise group. BSI (mg2/mm4) at the 4% tibial site will be measured using peripheral quantitative computed tomography (pQCT).

  Baseline, 6, and 12 months

Secondary Outcomes (2)

• Change in Bone Mineral Density (BMD) at the Spine (L1-L4) Based on Randomization to Control, Risedronate, or Exercise Group.

  Baseline,6, and 12 months

• Change in Serum Measures of Bone Resorption (Serum NTx) Based on Randomization to Control, Risedronate, or Exercise Group.

  Baseline, 6, 12 months

Study Arms (3)

Control

ACTIVE COMPARATOR

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.

Drug: Calcium Carbonate; Drug: Vitamin D3

Risedronate

EXPERIMENTAL

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.

Drug: Calcium Carbonate; Drug: Vitamin D3; Drug: Risedronate

Exercise

EXPERIMENTAL

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.

Drug: Calcium Carbonate; Drug: Vitamin D3; Behavioral: Bone-loading exercises

Interventions

Calcium Carbonate DRUG

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

Also known as: generic

Control; Exercise; Risedronate

Vitamin D3 DRUG

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

Also known as: generic

Control; Exercise; Risedronate

Risedronate DRUG

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

Also known as: Actonel

Risedronate

Bone-loading exercises BEHAVIORAL

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

Exercise

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead
• Creighton University Medical Center: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (36)

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• Kemmler W, Engelke K, Lauber D, Weineck J, Hensen J, Kalender WA. Exercise effects on fitness and bone mineral density in early postmenopausal women: 1-year EFOPS results. Med Sci Sports Exerc. 2002 Dec;34(12):2115-23. doi: 10.1097/00005768-200212000-00038.

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• Klentrou P, Slack J, Roy B, Ladouceur M. Effects of exercise training with weighted vests on bone turnover and isokinetic strength in postmenopausal women. J Aging Phys Act. 2007 Jul;15(3):287-99. doi: 10.1123/japa.15.3.287.

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• Prentice RL, Pettinger MB, Jackson RD, Wactawski-Wende J, Lacroix AZ, Anderson GL, Chlebowski RT, Manson JE, Van Horn L, Vitolins MZ, Datta M, LeBlanc ES, Cauley JA, Rossouw JE. Health risks and benefits from calcium and vitamin D supplementation: Women's Health Initiative clinical trial and cohort study. Osteoporos Int. 2013 Feb;24(2):567-80. doi: 10.1007/s00198-012-2224-2. Epub 2012 Dec 4.

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• Waltman N, Kupzyk KA, Flores LE, Mack LR, Lappe JM, Bilek LD. Bone-loading exercises versus risedronate for the prevention of osteoporosis in postmenopausal women with low bone mass: a randomized controlled trial. Osteoporos Int. 2022 Feb;33(2):475-486. doi: 10.1007/s00198-021-06083-2. Epub 2021 Sep 14.

  PMID: 34519832 RESULT

• Bilek LD, Waltman NL, Lappe JM, Kupzyk KA, Mack LR, Cullen DM, Berg K, Langel M, Meisinger M, Portelli-Trinidad A, Lang M. Protocol for a randomized controlled trial to compare bone-loading exercises with risedronate for preventing bone loss in osteopenic postmenopausal women. BMC Womens Health. 2016 Aug 30;16(1):59. doi: 10.1186/s12905-016-0339-x.

  PMID: 27576310 DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Calcium Carbonate; Drugs, Generic; Cholecalciferol; Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Pharmaceutical Preparations; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Laura Bilek
• Organization: University of Nebraska Medical Center

lbilek@unmc.edu

402-559-6923

Study Officials

• Nancy L Waltman, PhD, APRN-NP

  University of Nebraska

  PRINCIPAL INVESTIGATOR

• Laura Bilek, PT, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized to 3 treatment groups: Calcium + vitamin D only; risedronate and calcium + vitamin D; bone building exercises and calcium + vitamin D

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 10, 2014
• Study Start: February 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 5, 2023
• Results First Posted: June 27, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)