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OsteopeniaPhase 3HOPSNCT02186600

Heartland Osteoporosis Prevention Study

A Phase 3 study testing Calcium Carbonate, Vitamin D3 and Risedronate in people with Osteopenia, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 19 years and older, women only
Conditions the study is for
Osteopenia
What is being tested?
Calcium Carbonate, Vitamin D3 and Risedronate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
1 siteUnited States
Study dates
1 Feb 2015to 1 Jun 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

Other trials in United States

About this study

Official title: Randomized Control Trial of Bone Loading Exercises Versus Risedronate on Bone Health in Post-Menopausal Women

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.

Read the 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.

Conditions
Osteopenia
Being tested
Calcium Carbonate, Vitamin D3, Risedronate, Bone-loading exercises
Keywords
Low bone mass, Post-menopausal women, Bone mineral density, Bone structure, Bone turnover, Bone-loading exercises, calcium and vitamin D, risedronate
Medical subject headings
Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Calcium CarbonateDrug

    Also called generic

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

  • Vitamin D3Drug

    Also called generic

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

  • RisedronateDrug

    Also called Actonel

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

  • Bone-loading exercisesBehavioural

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

Study groups in NCT02186600
Study groupRoleWhat they receive
ControlActive comparatorWomen 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.
Receives: Drug: Calcium Carbonate; Drug: Vitamin D3
RisedronateExperimentalSubjects 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.
Receives: Drug: Calcium Carbonate; Drug: Vitamin D3; Drug: Risedronate
ExerciseExperimentalSubjects 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.
Receives: Drug: Calcium Carbonate; Drug: Vitamin D3; Behavioral: Bone-loading exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline, 6, and 12 months

Secondary outcomes (2)

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

    Bone mineral density is the gold standard for diagnosis of low bone mass and osteoporosis and will be measured at the spine using Dual Energy X-ray Absorptiometry (DXA).

    Measured: Baseline,6, and 12 months

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

    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.

    Measured: Baseline, 6, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2014 (estimated)
  2. Study start1 Feb 2015
  3. Primary completion1 Jun 2019
  4. Study completion1 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02186600
Sponsor's protocol ID
0378-14-FB
Acronym
HOPS
Status last verified
Sep 2023
First submitted
7 Jul 2014
Last updated
5 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bocalini DS, Serra AJ, dos Santos L, Murad N, Levy RF. Strength training preserves the bone mineral density of postmenopausal women without hormone replacement therapy. J Aging Health. 2009 Jun;21(3):519-27. doi: 10.1177/0898264309332839. Epub 2009 Feb 27.

    PubMed 19252142

  • Uusi-Rasi K, Kannus P, Cheng S, Sievanen H, Pasanen M, Heinonen A, Nenonen A, Halleen J, Fuerst T, Genant H, Vuori I. Effect of alendronate and exercise on bone and physical performance of postmenopausal women: a randomized controlled trial. Bone. 2003 Jul;33(1):132-43. doi: 10.1016/s8756-3282(03)00082-6.

    PubMed 12919708

  • Bergstrom I, Landgren B, Brinck J, Freyschuss B. Physical training preserves bone mineral density in postmenopausal women with forearm fractures and low bone mineral density. Osteoporos Int. 2008 Feb;19(2):177-83. doi: 10.1007/s00198-007-0445-6. Epub 2007 Sep 1.

    PubMed 17768587

  • Dane C, Dane B, Cetin A, Erginbas M. Effect of risedronate on biochemical marker of bone resorption in postmenopausal women with osteoporosis or osteopenia. Gynecol Endocrinol. 2008 Apr;24(4):207-13. doi: 10.1080/09513590801895617.

    PubMed 18382907

  • Cussler EC, Going SB, Houtkooper LB, Stanford VA, Blew RM, Flint-Wagner HG, Metcalfe LL, Choi JE, Lohman TG. Exercise frequency and calcium intake predict 4-year bone changes in postmenopausal women. Osteoporos Int. 2005 Dec;16(12):2129-41. doi: 10.1007/s00198-005-2014-1. Epub 2005 Nov 10.

    PubMed 16283062

  • Elders PJ, Netelenbos JC, Lips P, van Ginkel FC, Khoe E, Leeuwenkamp OR, Hackeng WH, van der Stelt PF. Calcium supplementation reduces vertebral bone loss in perimenopausal women: a controlled trial in 248 women between 46 and 55 years of age. J Clin Endocrinol Metab. 1991 Sep;73(3):533-40. doi: 10.1210/jcem-73-3-533.

    PubMed 1874931

  • Valimaki MJ, Farrerons-Minguella J, Halse J, Kroger H, Maroni M, Mulder H, Munoz-Torres M, Saaf M, Snorre Ofjord E. Effects of risedronate 5 mg/d on bone mineral density and bone turnover markers in late-postmenopausal women with osteopenia: a multinational, 24-month, randomized, double-blind, placebo-controlled, parallel-group, phase III trial. Clin Ther. 2007 Sep;29(9):1937-49. doi: 10.1016/j.clinthera.2007.09.017.

    PubMed 18035193

  • Vainionpaa A, Korpelainen R, Sievanen H, Vihriala E, Leppaluoto J, Jamsa T. Effect of impact exercise and its intensity on bone geometry at weight-bearing tibia and femur. Bone. 2007 Mar;40(3):604-11. doi: 10.1016/j.bone.2006.10.005. Epub 2006 Nov 30.

    PubMed 17140871

  • Waltman NL, Twiss JJ, Ott CD, Gross GJ, Lindsey AM, Moore TE, Berg K, Kupzyk K. The effect of weight training on bone mineral density and bone turnover in postmenopausal breast cancer survivors with bone loss: a 24-month randomized controlled trial. Osteoporos Int. 2010 Aug;21(8):1361-9. doi: 10.1007/s00198-009-1083-y. Epub 2009 Oct 3.

    PubMed 19802506

  • Fogelman I, Ribot C, Smith R, Ethgen D, Sod E, Reginster JY. Risedronate reverses bone loss in postmenopausal women with low bone mass: results from a multinational, double-blind, placebo-controlled trial. BMD-MN Study Group. J Clin Endocrinol Metab. 2000 May;85(5):1895-900. doi: 10.1210/jcem.85.5.6603.

    PubMed 10843171

  • Going S, Lohman T, Houtkooper L, Metcalfe L, Flint-Wagner H, Blew R, Stanford V, Cussler E, Martin J, Teixeira P, Harris M, Milliken L, Figueroa-Galvez A, Weber J. Effects of exercise on bone mineral density in calcium-replete postmenopausal women with and without hormone replacement therapy. Osteoporos Int. 2003 Aug;14(8):637-43. doi: 10.1007/s00198-003-1436-x. Epub 2003 Jul 3.

    PubMed 12844212

  • 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.

    PubMed 12471325

  • Vainionpaa A, Korpelainen R, Vaananen HK, Haapalahti J, Jamsa T, Leppaluoto J. Effect of impact exercise on bone metabolism. Osteoporos Int. 2009 Oct;20(10):1725-33. doi: 10.1007/s00198-009-0881-6. Epub 2009 Mar 5.

    PubMed 19262975

  • 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.

    PubMed 17724395

  • 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.

    PubMed 23208074

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Calcium Carbonate, Vitamin D3 and Risedronate in people with Osteopenia, run by University of Nebraska at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Bone Strength Index of the Distal Tibia Based on Randomization to Control, Risedronate, or Exercise Group. (time frame: Baseline, 6, and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02186600, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.

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Heartland Osteoporosis Prevention Study (NCT02186600) | AzTrials