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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


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.


Minimum age: 19 Years. Maximum age: N/A. Gender(s): Female.


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:

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Whyte MP. Atypical femoral fractures, bisphosphonates, and adult hypophosphatasia. J Bone Miner Res. 2009 Jun;24(6):1132-4. doi: 10.1359/jbmr.081253.

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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.

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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

Page last updated: August 20, 2015

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