Osteoporosis Clinical Trial
— BRRIEOfficial title:
Bone Response to Resistance and Impact Exercise (BRRIE) in Women on Antiresorptive Medications: A Randomized Controlled Trial
NCT number | NCT04275011 |
Other study ID # | 41153 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2, 2020 |
Est. completion date | March 16, 2020 |
Verified date | August 2022 |
Source | University of Waterloo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 26 |
Est. completion date | March 16, 2020 |
Est. primary completion date | March 16, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Waterloo | Waterloo | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Waterloo |
Canada,
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. — View Citation
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. Epub 2007 Mar 29. Review. — View Citation
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. — View Citation
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. Review. — View Citation
Chilibeck PD, Davison KS, Whiting SJ, Suzuki Y, Janzen CL, Peloso P. The effect of strength training combined with bisphosphonate (etidronate) therapy on bone mineral, lean tissue, and fat mass in postmenopausal women. Can J Physiol Pharmacol. 2002 Oct;80(10):941-50. — View Citation
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. Erratum in: Med Sci Sports Exerc. 2012 Apr;44(4):770. — View Citation
Hamilton CJ, Swan VJ, Jamal SA. The effects of exercise and physical activity participation on bone mass and geometry in postmenopausal women: a systematic review of pQCT studies. Osteoporos Int. 2010 Jan;21(1):11-23. doi: 10.1007/s00198-009-0967-1. Epub 2009 Jun 6. Review. — View Citation
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;(7):CD000333. doi: 10.1002/14651858.CD000333.pub2. Review. — View Citation
Kaastad TS, Nordsletten L, Narum S, Madsen JE, Haug E, Reikerås 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. — View Citation
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. Review. — View Citation
Moester MJ, Papapoulos SE, Löwik 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. Review. — View Citation
Morales-Santana S, Díez-Pérez A, Olmos JM, Nogués X, Sosa M, Díaz-Curiel M, Pérez-Castrillón JL, Pérez-Cano R, Torrijos A, Jodar E, Rio LD, Caeiro-Rey JR, Reyes-García R, García-Fontana B, González-Macías J, Muñoz-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. — View Citation
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. — View Citation
Uusi-Rasi K, Kannus P, Cheng S, Sievänen 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. — View Citation
Vainionpää A, Korpelainen R, Väänänen HK, Haapalahti J, Jämsä T, Leppäluoto 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. — View Citation
van Bezooijen RL, ten Dijke P, Papapoulos SE, Löwik CW. SOST/sclerostin, an osteocyte-derived negative regulator of bone formation. Cytokine Growth Factor Rev. 2005 Jun;16(3):319-27. Review. — View Citation
Watson S, Weeks B, Weis L, Harding A, Horan S, Beck B. High-Intensity Resistance and Impact Training Improves Bone Mineral Density and Physical Function in Postmenopausal Women With Osteopenia and Osteoporosis: The LIFTMOR Randomized Controlled Trial. J Bone Miner Res. 2019 Mar;34(3):572. doi: 10.1002/jbmr.3659. Epub 2019 Feb 25. — View Citation
Watson SL, Weeks BK, Weis LJ, Horan SA, Beck BR. Heavy resistance training is safe and improves bone, function, and stature in postmenopausal women with low to very low bone mass: novel early findings from the LIFTMOR trial. Osteoporos Int. 2015 Dec;26(12):2889-94. doi: 10.1007/s00198-015-3263-2. Epub 2015 Aug 5. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Descriptive Data - Demographic information | We will collect data such as demographic information including date of birth, race, formal education and marital status. | Baseline | |
Secondary | Descriptive Data - Medical History | Current and past medical history (including family history) will be collected including recent/past drug therapies and bone-related medications, reproductive history (e.g. age at menarche or menopause), past surgical history, falls risk (e.g. number of falls within the last 12 months) and fracture history, as well as current alcohol consumption and smoking status. | Baseline | |
Secondary | Descriptive Data - Physical Activity | Baseline physical activity will be assessed using a Bone-specific Physical activity Questionnaire (BPAQ), and by asking participants to wear accelerometers for one week prior to participating in the exercise program. | Baseline | |
Secondary | Descriptive Data - Dietary Intake | To assess dietary energy, calcium and protein intake, participants will be asked to complete an Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool (Canada Version). | Baseline, 3-months, and 6-months | |
Secondary | Other bone biomarkers - Serum P1NP | Serum P1NP will be be measured by the same single blinded assessor. P1NP will be measured using Human Total Procollagen Type I Intact N-Terminal Propeptide (TP1NP) ELISA Kit supplied by MyBioSource (MyBioSource Inc., San Diego, California, USA). | Baseline, 3-month and 6-month follow up. | |
Secondary | Other bone biomarkers - CTX | CTX will be measured in the blood by the same single blinded assessor. Beta-crosslaps CTX will be measured using Human beta-crosslaps (bCTx) ELISA Kit supplied by Cusabio (Cusabio Technology LLC, Houston, Texas, USA). | Baseline, 3-month and 6-month follow up. | |
Secondary | Other bone biomarkers - Parathyroid Hormone | PTH will be measured in the blood by the same single blinded assessor. Parathyroid hormone will be measured using ab230931 Human PTH SimpleStep ELISA® Kit supplied by Abcam (Abcam Inc., Toronto, Ontario, Canada). | Baseline, 3-month and 6-month follow up. | |
Secondary | Other bone biomarkers - Vitamin D | Vitamin D will be measured in the blood by the same single blinded assessor. Vitamin D will be measured using Human 25-Hydroxyvitamin D-1 Aplha Hydroxylase Mitochondrial (CYPB27B1) ELISA® Kit supplied by Cusabio (Cusabio Technology LLC, Houston, Texas, USA). | Baseline, 3-month and 6-month follow up. | |
Secondary | Other bone biomarkers - Calcium | Calcium will be measured in the blood by the same single blinded assessor. Calcium will be measured using ab112115 Calcium Quantification Kit - Red Fluorescence supplied by Abcam (Abcam Inc., Toronto, Ontario, Canada). | Baseline, 3-month and 6-month follow up. | |
Secondary | Physical function and mobility - 40 metre Fast-paced Walk | Physical function and mobility will be assessed using the 40 m fast-paced walk test. Time to complete test will be recorded. | Baseline, 3-month and 6-month follow up. | |
Secondary | Physical function and mobility - 30-second Sit-to-Stand Test | Physical function and mobility will be assessed using the 30-second sit-to-stand test. Number of sit-to-stand repetitions performed in 30 seconds will be recorded. | Baseline, 3-month and 6-month follow up. | |
Secondary | Physical function and mobility - 4-square Step Test | Physical function and mobility will be assessed using the 4-square step test. Time to complete test will be recorded. | Baseline, 3-month and 6-month follow up. | |
Secondary | Physical function and mobility - Stair Climb Test | Physical function and mobility will be assessed using the stair climb test. Time to complete test will be recorded. | Baseline, 3-month and 6-month follow up. | |
Secondary | Quality of Life - EQ-5D | The 5 level EuroQol EQ-5D instrument (EQ-5D-5L) will be used to assess the quality of life of the participants. The EQ-5D-5L instrument includes a descriptive system that is comprised of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores are coded from 11111 (no problems in all dimensions) to 55555 (extreme problems in all dimensions). A lower score is better. There is also a visual analogue scale that is used to measure the individuals self-rated overall health on a particular day. The visual analogue scale is scored from 0 (worst health imaginable) to 100 (best health imaginable). | Baseline, 3-month and 6-month follow up. | |
Secondary | Quality of Life - QUALEFFO-41 | The Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) questionnaire will be used to assess quality of life of the participants. The QUALEFFO-41 questionnaire is specific to people with osteoporosis and includes the following domains: pain, activities of daily living, mobility, leisure and social activity, general health perception, and mental function. Scores range from 0-100, lower is better. | Baseline, 3-month and 6-month follow up. | |
Secondary | Bone Mineral Density | Certified technologists, blind to group allocation, will assess bone mineral density (g/cm2) at the spine (L1-L4) and femoral neck using a dual energy X-ray absorptiometry (DXA) scan (Hologic Inc, Bedford, MA). | Baseline and 6 months. | |
Secondary | Body Composition | Certified technologists, blind to group allocation, will assess body mass (kg) and use this to determine whole body fat- and bone-free lean mass (FBFM, in kg) and appendicular lean mass (ALM, in kg) and its index (ALMI) using a dual energy X-ray absorptiometry (DXA) scan (Hologic Inc, Bedford, MA). | Baseline and 6 months. | |
Secondary | Feasibility (Number of participants retained) | Feasibility outcomes will include a record of the number of participants recruited and retained, and the acceptability of the attention control group (e.g., low dropout rate after randomization). | 6 months. | |
Secondary | Feasibility (Adherence) | The exercise trainers will be provided with an attendance sheet at every exercise session to monitor the number of exercise sessions participants attend to determine adherence. | Through study, 6 months. | |
Secondary | Feasibility (Acceptability) | We will conduct one exit interview to determine the participants' perspective on the intervention and control groups, and if they understood the purpose of the study. | 6 months. | |
Secondary | Falls | Falls will be recorded using a prospective notification system to assess the number of falls, the number of fallers/non-fallers/frequent fallers and the fall rate. Participants will be asked weekly to report any falls that occurred outside of, and during, the exercise training program. Participants will be instructed to provide their weekly assessments to the exercise trainers when they attend their scheduled exercise sessions. Exercise trainers will check to ensure completion, confirm the date, injuries and hospitalization after a fall has been reported, and will follow-up with participants who have missing assessments. | Through study, up to 6 months | |
Secondary | Fractures | Participants will also be asked to report any new fractures or injuries, related or unrelated to the exercise training. Exercise trainers will complete an adverse event report to ascertain the cause and timing of any injuries. To verify fracture details, written consent will be obtained to abstract data from medical records. | Through study, up to 6 months | |
Secondary | Adverse Events | According to Health Canada a serious adverse event is defined as ". . . an event (experience) or reaction is any untoward medical occurrence that at any dose (a) results in death, (b) is life-threatening, (c) requires inpatient hospitalization or prolongation of existing hospitalization, (d) results in persistent or significant disability/ incapacity, or (e) is a congenital anomaly/birth defect". Whereas a non-serious adverse event includes bone/limb pain, myalgia or muscle cramps (e.g. pain, cramps or aches), and injuries. | Through study, up to 6 months. |
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