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Heartland Osteoporosis Prevention Study (HOPS)

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ClinicalTrials.gov Identifier: NCT02186600
Recruitment Status : Unknown
Verified September 2018 by Nancy L. Waltman, BSN MSN PhD, University of Nebraska.
Recruitment status was:  Active, not recruiting
First Posted : July 10, 2014
Last Update Posted : September 27, 2018
Sponsor:
Collaborators:
Creighton University Medical Center
University of Nebraska
Information provided by (Responsible Party):
Nancy L. Waltman, BSN MSN PhD, University of Nebraska

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteopenia Drug: Calcium Carbonate Drug: Vitamin D3 Drug: Risedronate Behavioral: Bone-loading exercises Phase 3

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 menopause. Women will be randomized to one control and 2 treatment groups (n =103 per group): 1) calcium + vitamin D (CaD) alone (Control); 2) Bisphosphonate (BP) plus optimal CaD (Risedronate); and 3) a bone loading exercise program plus optimal CaD (Exercise). Our central hypothesis is that improvements in bone health will be greater in subjects randomized to the exercise group compared to subjects in either the control or risedronate groups. Specific Aims: Aims 1, 2, and 3 are to compare control, risedronate, and exercise group subjects on changes in bone structure at the tibia and hip (measured by pQCT and Hip Structural Analysis) (Aim 1) ; on changes in BMD at the total hip, femoral neck, and spine (Aim 2); and on changes in serum markers of bone formation and resorption (Aim 3). In addition, Aim 4 will explore relationships between adherence to exercise (% sessions attended) or adherence to risedronate (% pills taken) and changes in bone structure.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 309 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized to 3 treatment groups: Calcium + vitamin D only; risedronate and calcium + vitamin D; bone building exercises and calcium + vitamin D
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Bone Loading Exercises Versus Risedronate on Bone Health in Post-Menopausal Women
Actual Study Start Date : February 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control
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
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.
Experimental: Risedronate
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
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.
Other Name: Actonel
Experimental: Exercise
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
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.

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


Outcome Measures
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Primary Outcome Measures :
  1. Change in bone structure at hip and tibia based on randomization to Control, Risedronate, or Exercise group. [ Time Frame: Baseline, 6, and 12 months ]
    Bone structure will be measured at the hip using Hip Structural Analysis (HSA) software and DXA testing. Bone structure will be measured at the 4% and 66% tibial sites using peripheral quantitative computed tomography (pQCT).


Secondary Outcome Measures :
  1. Change in bone mineral density (BMD) at hip and spine based on randomization to Control, Risedronate, or Exercise group. [ Time Frame: Baseline,6, and 12 months ]
    Bone mineral density is the gold standard for diagnosis of low bone mass and osteoporosis and will be measured at the hip and spine using Dual Energy X-ray Absorptiometry (DXA).

  2. Change in serum measures of bone resorption (Serum NTx) and bone formation (AlkphaseB) based on randomization to Control, Risedronate, or Exercise group. [ Time Frame: Baseline, 6, 12 months ]
    Bone turnover is the process of removing old bone (resorption by osteoclasts) and replacing it with new bone (formation by osteoblasts). Menopause results in a brief period (~5 years) of accelerated turnover with resorption far exceeding formation. In this study, resorption will be measured by Serum NTx and formation by AlkphaseB


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186600


Locations
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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-4420
Sponsors and Collaborators
Nancy L. Waltman, BSN MSN PhD
Creighton University Medical Center
University of Nebraska
Investigators
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Principal Investigator: Nancy L Waltman, PhD, APRN-NP University of Nebraska
Principal Investigator: Laura Bilek, PT, PhD University of Nebraska
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nancy L. Waltman, BSN MSN PhD, Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT02186600    
Other Study ID Numbers: 378-14
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nancy L. Waltman, BSN MSN PhD, University of Nebraska:
Low bone mass
Post-menopausal women
Bone mineral density
Bone structure
 Bone turnover
Bone-loading exercises
calcium and vitamin D
risedronate
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Cholecalciferol
Risedronic Acid
Calcium Carbonate
Calcium
Vitamins
 Micronutrients
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Calcium Channel Blockers
Membrane Transport Modulators