Bone Response to Exercise in Women on Antiresorptive Medications

NCT04275011 | Terminated

• 1 other identifier: 41153
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Performing resistance training and impact exercise at a moderate to high intensity may help prevent bone loss. However, medications used to treat bone diseases such as osteoporosis reduce the activity of bone cells. The investigators are unsure whether bone cells will still respond to exercise in people on osteoporosis medications. Therefore, investigators have designed a study to compare bone response to moderate-high intensity exercise that involves resistance training and impact exercise versus posture and low intensity balance exercises. Women taking osteoporosis medication will be equally and randomly assigned to one of the exercise groups. There will be 23 participants per group and both exercise programs will be performed over a span of 6 months, twice weekly, for approximately 30-45 minutes per session. Investigators will measure sclerostin, a bone-related protein found in the blood, to see if there are any changes after 3 months of training. Higher levels of sclerostin may result in greater bone breakdown. It is expected that the moderate-high intensity exercise program will decrease sclerostin levels more than low intensity training. Further, changes in sclerostin levels during the 6-month exercise intervention will be explored. The effects of the exercise program on other bone markers in the blood, physical ability, and quality of life will be reported. The willingness of the participants to perform the exercise program and the safety of the exercises provided will also be assessed.

Conditions

Osteoporosis; Bone Loss

Keywords

Exercise; Progressive Resistance Training; Impact Exercise; Anti-resorptive medication

Outcome Measures

Primary Outcomes (1)

• Change from baseline Serum Sclerostin at 3 months and 6 months.

  The primary outcome measure will be serum sclerostin. Venous blood samples will be taken by experienced phlebotomists between 8:00 and 10:00 am, after an overnight fast (8-12 hours). Participants will also be instructed to refrain from exercise for 48 hours prior to blood collection. An assessor who is blind to group allocation will measure sclerostin using ab221836 Human SOST SimpleStep ELISA® (Enzyme-Linked Immunosorbent Assay) supplied by Abcam (Abcam Inc., Toronto, Ontario, Canada).

  Baseline, 3-month and 6-month follow up.

Secondary Outcomes (23)

• Descriptive Data - Demographic information

  Baseline

• Descriptive Data - Medical History

  Baseline

• Descriptive Data - Physical Activity

  Baseline

• Descriptive Data - Dietary Intake

  Baseline, 3-months, and 6-months

• Other bone biomarkers - Serum P1NP

  Baseline, 3-month and 6-month follow up.

Study Arms (2)

Static Posture and Balance Exercise

ACTIVE COMPARATOR

Participants in the control group will receive equal attention through a static posture and balance exercise class two times per week, in a small group setting.

Other: Static Balance and Postural Exercise

Progressive Resistance and Impact Exercise

EXPERIMENTAL

The exercise program will include two progressive resistance and impact exercise training sessions per week in a small group setting. Exercises will be individually tailored to the participants' abilities and designed to achieve a maximum 80-85% 1RM.

Other: Progressive Resistance and Impact Exercise

Interventions

Progressive Resistance and Impact Exercise OTHER

Full body resistance and impact exercises will be performed twice a week for 30-45 minutes over a 6 month period. There will be at least one day of rest between scheduled exercise sessions. Participants will be individually prescribed variations of push, pull, squat, lift and carry movements targeting major muscle groups that they can safely complete, and accessory exercises to help develop movement patterns. Exercises will challenge both the upper and lower body using functional movement patterns. Each muscle group will be trained twice a week. During the first month, participants will focus on completing exercises with good form at a low intensity. Once form is mastered, exercises will be progressed (by increasing load, or challenge of the movement) to a moderate to high exercise intensity (80-85% 1RM) so that the participant can complete a maximum of 8 (\~80% 1RM) or 6 (\~85% 1RM) repetitions with 1-2 repetitions in reserve for 3 sets at a rating of perceived exertion (RPE) of 8-9.

Progressive Resistance and Impact Exercise

Static Balance and Postural Exercise OTHER

Participants in the attention control group will perform static posture and balance exercises (e.g., low intensity yoga poses) and will be given the same attention as the participants in the intervention group. The small group exercises will be performed twice a week, 30-45 minutes per session, over 6 months, with at least one day of rest between each session. The exercise program will be supervised by a certified personal trainer and yoga instructor who is BoneFit trained.

Static Posture and Balance Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over 18 years of age AND
• Taking anti-resorptive medications for at least 12 months eg. risedronate (Actonel), alendronate (Fosamax, Fosavance), etidronate (Didronel, Didrocal), zoledronic acid (Aclasta, Reclast, Zometa), pamidronate (Aredia) and denosumab (Prolia, Xgeva).

You may not qualify if:

• Not able to communicate in English
• Already participating in structured progressive resistance exercise or impact training exercise program; presence of any progressive neurological disorders that can possibly prevent study completion; unable to stand or walk 10 m with or without gait aid; does not have the mental capacity to provide informed consent; have any contraindications to exercise as determined by a physician.
• Individuals that have had a fracture in the last 6 months need to have completed any immobilization (eg. casting) and post-fracture rehabilitation, and will need physician consent to participate in the study. Individuals with previous fractures (\> 6 months ago) will not be excluded.

Sponsors & Collaborators

• University of Waterloo: lead

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

Related Publications (18)

• Swift JM, Nilsson MI, Hogan HA, Sumner LR, Bloomfield SA. Simulated resistance training during hindlimb unloading abolishes disuse bone loss and maintains muscle strength. J Bone Miner Res. 2010 Mar;25(3):564-74. doi: 10.1359/jbmr.090811.

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• Martyn-St James M, Carroll S. A meta-analysis of impact exercise on postmenopausal bone loss: the case for mixed loading exercise programmes. Br J Sports Med. 2009 Dec;43(12):898-908. doi: 10.1136/bjsm.2008.052704. Epub 2008 Nov 3.

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• Basat H, Esmaeilzadeh S, Eskiyurt N. The effects of strengthening and high-impact exercises on bone metabolism and quality of life in postmenopausal women: a randomized controlled trial. J Back Musculoskelet Rehabil. 2013;26(4):427-35. doi: 10.3233/BMR-130402.

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• Erickson CR, Vukovich MD. Osteogenic index and changes in bone markers during a jump training program: a pilot study. Med Sci Sports Exerc. 2010 Aug;42(8):1485-92. doi: 10.1249/MSS.0b013e3181d0fa7a.

  PMID: 20139789 BACKGROUND

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  PMID: 19504035 BACKGROUND

• Beck BR, Daly RM, Singh MA, Taaffe DR. Exercise and Sports Science Australia (ESSA) position statement on exercise prescription for the prevention and management of osteoporosis. J Sci Med Sport. 2017 May;20(5):438-445. doi: 10.1016/j.jsams.2016.10.001. Epub 2016 Oct 31.

  PMID: 27840033 BACKGROUND

• Kaastad TS, Nordsletten L, Narum S, Madsen JE, Haug E, Reikeras O. Training increases the in vivo fracture strength in osteoporotic bone. Protection by muscle contraction examined in rat tibiae. Acta Orthop Scand. 1996 Aug;67(4):371-6. doi: 10.3109/17453679609002334.

  PMID: 8792742 BACKGROUND

• Howe TE, Shea B, Dawson LJ, Downie F, Murray A, Ross C, Harbour RT, Caldwell LM, Creed G. Exercise for preventing and treating osteoporosis in postmenopausal women. Cochrane Database Syst Rev. 2011 Jul 6;2011(7):CD000333. doi: 10.1002/14651858.CD000333.pub2.

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• Baron R, Rawadi G. Targeting the Wnt/beta-catenin pathway to regulate bone formation in the adult skeleton. Endocrinology. 2007 Jun;148(6):2635-43. doi: 10.1210/en.2007-0270. Epub 2007 Mar 29.

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• van Bezooijen RL, ten Dijke P, Papapoulos SE, Lowik CW. SOST/sclerostin, an osteocyte-derived negative regulator of bone formation. Cytokine Growth Factor Rev. 2005 Jun;16(3):319-27. doi: 10.1016/j.cytogfr.2005.02.005.

  PMID: 15869900 BACKGROUND

• Moester MJ, Papapoulos SE, Lowik CW, van Bezooijen RL. Sclerostin: current knowledge and future perspectives. Calcif Tissue Int. 2010 Aug;87(2):99-107. doi: 10.1007/s00223-010-9372-1. Epub 2010 May 15.

  PMID: 20473488 BACKGROUND

• Morales-Santana S, Diez-Perez A, Olmos JM, Nogues X, Sosa M, Diaz-Curiel M, Perez-Castrillon JL, Perez-Cano R, Torrijos A, Jodar E, Rio LD, Caeiro-Rey JR, Reyes-Garcia R, Garcia-Fontana B, Gonzalez-Macias J, Munoz-Torres M. Circulating sclerostin and estradiol levels are associated with inadequate response to bisphosphonates in postmenopausal women with osteoporosis. Maturitas. 2015 Dec;82(4):402-10. doi: 10.1016/j.maturitas.2015.08.007. Epub 2015 Aug 20.

  PMID: 26358930 BACKGROUND

• Ardawi MS, Rouzi AA, Qari MH. Physical activity in relation to serum sclerostin, insulin-like growth factor-1, and bone turnover markers in healthy premenopausal women: a cross-sectional and a longitudinal study. J Clin Endocrinol Metab. 2012 Oct;97(10):3691-9. doi: 10.1210/jc.2011-3361. Epub 2012 Aug 3.

  PMID: 22865898 BACKGROUND

• 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.

  PMID: 19262975 BACKGROUND

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Motor Activity

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Lora M Giangregorio, PhD

  University of Waterloo, Schlegel-UW Research Institute for Aging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Using a computer-generated random selection process, participants will be randomized in a 1:1 allocation ratio in blocks which will be randomly determined. Allocation will be concealed from all but the person performing the randomization, the participants, and the exercise trainers. Although the participants cannot be blinded to the assigned exercise group, they will simply be informed that the purpose of the study is to compare two different exercise programs with no indication regarding the study hypothesis. Research staff blinded to group allocation will have access to the assessment forms. An alternate research staff member will collect or enter data that may cause unblinding (e.g., randomization, exercise adherence logs). Exercise trainers who are unblinded to group allocation will have access to the exercise training manual. Completed outcome assessments and exercise training data will be stored in separate password protected files to avoid exposing group allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-blinded RCT comparing moderate-high progressive resistance training and impact exercise to an attention control who will be performing static posture and balance exercises.

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 19, 2020
• Study Start: January 2, 2020
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: September 2, 2022

Record last verified: 2022-08

Locations

CA (1)