Study Comparing Bone Loss in Women Who Take Calcium and Vitamin D With Women Who Also Take Risedronate or Exercise
Information source: University of Nebraska
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteopenia.
Intervention: Calcium carbonate (Drug); Vitamin D3 (Drug); Risedronate (Drug); Bone-loading exercises (Behavioral)
Phase: Phase 3
Status: Recruiting
Sponsored by: Nancy L. Waltman, BSN MSN PhD Official(s) and/or principal investigator(s): Nancy L Waltman, PhD, APRN-NP, Principal Investigator, Affiliation: University of Nebraska Laura Bilek, PT, PhD, Principal Investigator, Affiliation: University of Nebraska
Overall contact: Nancy L Waltman, PhD, APRN-NP, Phone: 402-472-7354, Email: nwaltman@unmc.edu
Summary
The purpose of this study is to identify the best way to prevent bone loss in the first
years after menopause. The HOPE 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.
Clinical Details
Official title: Randomized Control Trial of Bone Loading Exercises Versus Risedronate on Bone Health in Post-Menopausal Women
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in bone structure at hip and tibia based on randomization to Control, Risedronate, or Exercise group.
Secondary outcome: Change in bone mineral density (BMD) at hip and spine based on randomization to Control, Risedronate, or Exercise group.Change in serum measures of bone resorption (Serum NTx) and bone formation (AlkphaseB) based on randomization to Control, Risedronate, or Exercise group.
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) optimal calcium + vitamin D (optimal 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.
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Female.
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 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 two or more times weekly
- Weigh >300 lbs
- Have abnormal results for the following laboratory tests: serum 25(OH)D; serum
creatinine; serum calcium; PTH; 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.
Locations and Contacts
Nancy L Waltman, PhD, APRN-NP, Phone: 402-472-7354, Email: nwaltman@unmc.edu
University of Nebraska Medical Center, Omaha, Nebraska 68198-4420, United States; Recruiting Nancy L Waltman, PhD, APRN-NP, Phone: 402-472-7354, Email: nwaltman@unmc.edu Laura Bilek, PT, PhD, Phone: 402-559-6597, Email: lbilek@unmc.edu
Additional Information
Related publications: 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. 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. Review. Erratum in: Am J Clin Nutr. 2006 Nov;84(5):1253. Dosage error in published abstract; MEDLINE/PubMed abstract corrected. Am J Clin Nutr. 2007 Sep;86(3):809. Dosage error in published abstract; MEDLINE/PubMed abstract corrected. 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. Review. Ott SM. Long-term safety of bisphosphonates. J Clin Endocrinol Metab. 2005 Mar;90(3):1897-9. 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. 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. Review. van der Linden JC, Weinans H. Effects of microarchitecture on bone strength. Curr Osteoporos Rep. 2007 Jun;5(2):56-61. Review. Akhter MP, Lappe JM, Davies KM, Recker RR. Transmenopausal changes in the trabecular bone structure. Bone. 2007 Jul;41(1):111-6. 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. Review. 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. Management of osteoporosis in postmenopausal women: 2010 position statement of The North American Menopause Society. Menopause. 2010 Jan-Feb;17(1):25-54; quiz 55-6. doi: 10.1097/gme.0b013e3181c617e6. Lappe JM, Davies KM, Travers-Gustafson D, Heaney RP. Vitamin D status in a rural postmenopausal female population. J Am Coll Nutr. 2006 Oct;25(5):395-402. 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. 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. Review. Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb. Maddalozzo GF, Widrick JJ, Cardinal BJ, Winters-Stone KM, Hoffman MA, Snow CM. The effects of hormone replacement therapy and resistance training on spine bone mineral density in early postmenopausal women. Bone. 2007 May;40(5):1244-51. Epub 2006 Dec 29. 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.
Starting date: February 2015
Last updated: June 8, 2015
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