Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
276 participants
INTERVENTIONAL
2015-02-01
2019-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Calcium Carbonate
Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3
Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
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.
Calcium Carbonate
Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3
Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
Risedronate
Risedronate 35 mg orally will be ingested weekly by subjects in Risedronate group.
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.
Calcium Carbonate
Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3
Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
Bone-loading exercises
Subjects will participate in bone loading exercises (weight-bearing and resistance) three times weekly at community YMCAs.
Interventions
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Calcium Carbonate
Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Vitamin D3
Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
Risedronate
Risedronate 35 mg orally will be ingested weekly by subjects in Risedronate group.
Bone-loading exercises
Subjects will participate in bone loading exercises (weight-bearing and resistance) three times weekly at community YMCAs.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
19 Years
FEMALE
No
Sponsors
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Creighton University Medical Center
OTHER
University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Nancy L Waltman, PhD, APRN-NP
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Laura Bilek, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Locations
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University of Nebraska Medical Center
Omaha, Nebraska, United States
Countries
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References
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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.
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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.
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.
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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.
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.
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.
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.
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.
Somford MP, Geurts GF, den Teuling JW, Thomassen BJ, Draijer WF. Long-Term Alendronate Use Not without Consequences? Int J Rheumatol. 2009;2009:253432. doi: 10.1155/2009/253432. Epub 2010 Jan 27.
Whyte MP. Atypical femoral fractures, bisphosphonates, and adult hypophosphatasia. J Bone Miner Res. 2009 Jun;24(6):1132-4. doi: 10.1359/jbmr.081253.
Caulfield MP, Reitz RE. Biochemical markers of bone turnover and their utility in osteoporosis. MLO Med Lab Obs. 2004 Apr;36(4):34-7. No abstract available.
Bischoff-Ferrari HA, Giovannucci E, Willett WC, Dietrich T, Dawson-Hughes B. Estimation of optimal serum concentrations of 25-hydroxyvitamin D for multiple health outcomes. Am J Clin Nutr. 2006 Jul;84(1):18-28. doi: 10.1093/ajcn/84.1.18.
Bischoff-Ferrari HA, Willett WC, Wong JB, Giovannucci E, Dietrich T, Dawson-Hughes B. Fracture prevention with vitamin D supplementation: a meta-analysis of randomized controlled trials. JAMA. 2005 May 11;293(18):2257-64. doi: 10.1001/jama.293.18.2257.
Ott SM. Long-term safety of bisphosphonates. J Clin Endocrinol Metab. 2005 Mar;90(3):1897-9. doi: 10.1210/jc.2005-0057. No abstract available.
Schneider JP. Should bisphosphonates be continued indefinitely? An unusual fracture in a healthy woman on long-term alendronate. Geriatrics. 2006 Jan;61(1):31-3. No abstract available.
Hamdy RC, Petak SM, Lenchik L; International Society for Clinical Densitometry Position Development Panel and Scientific Advisory Committee. Which central dual X-ray absorptiometry skeletal sites and regions of interest should be used to determine the diagnosis of osteoporosis? J Clin Densitom. 2002;5 Suppl:S11-8. doi: 10.1385/jcd:5:3s:s11.
van der Linden JC, Weinans H. Effects of microarchitecture on bone strength. Curr Osteoporos Rep. 2007 Jun;5(2):56-61. doi: 10.1007/s11914-007-0003-3.
Akhter MP, Lappe JM, Davies KM, Recker RR. Transmenopausal changes in the trabecular bone structure. Bone. 2007 Jul;41(1):111-6. doi: 10.1016/j.bone.2007.03.019. Epub 2007 Apr 10.
Beck TJ. Extending DXA beyond bone mineral density: understanding hip structure analysis. Curr Osteoporos Rep. 2007 Jun;5(2):49-55. doi: 10.1007/s11914-007-0002-4.
Twiss JJ, Waltman NL, Berg K, Ott CD, Gross GJ, Lindsey AM. An exercise intervention for breast cancer survivors with bone loss. J Nurs Scholarsh. 2009 Mar;41(1):20-7. doi: 10.1111/j.1547-5069.2009.01247.x.
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Borah B, Dufresne TE, Chmielewski PA, Johnson TD, Chines A, Manhart MD. Risedronate preserves bone architecture in postmenopausal women with osteoporosis as measured by three-dimensional microcomputed tomography. Bone. 2004 Apr;34(4):736-46. doi: 10.1016/j.bone.2003.12.013.
Kanis JA, Hans D, Cooper C, Baim S, Bilezikian JP, Binkley N, Cauley JA, Compston JE, Dawson-Hughes B, El-Hajj Fuleihan G, Johansson H, Leslie WD, Lewiecki EM, Luckey M, Oden A, Papapoulos SE, Poiana C, Rizzoli R, Wahl DA, McCloskey EV; Task Force of the FRAX Initiative. Interpretation and use of FRAX in clinical practice. Osteoporos Int. 2011 Sep;22(9):2395-411. doi: 10.1007/s00198-011-1713-z. Epub 2011 Jul 21.
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Ashe MC, Gorman E, Khan KM, Brasher PM, Cooper DM, McKay HA, Liu-Ambrose T. Does frequency of resistance training affect tibial cortical bone density in older women? A randomized controlled trial. Osteoporos Int. 2013 Feb;24(2):623-32. doi: 10.1007/s00198-012-2000-3. Epub 2012 May 12.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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0378-14-FB
Identifier Type: -
Identifier Source: org_study_id
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