Osteoporosis Clinical Trial
Official title:
Finding the Optimal Resistance Training Intensity For Your Bones: A Randomized Controlled Trial (FORTIFY Bones)
Osteoporosis is a bone disease that can result in fractures, disability and an increased risk of premature death. Exercise is recommended for fall and fracture prevention, but health care professionals often recommend walking or lower intensity community exercise classes, which may not be effective for building bone. Further, individuals with osteoporosis are often told to avoid lifting or moving in certain ways, which creates fear and activity avoidance. Conversely, research suggests that to stimulate bone, you need higher loads on bone, with either higher intensity resistance training or impact exercise - the types of things people with low bone mass are told to avoid. Our study will examine different types of exercise intensity and how they translate to building bone in people with low bone mineral density (BMD).
Status | Recruiting |
Enrollment | 324 |
Est. completion date | September 2026 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - Age 50 or over - Has received 2 vaccines for COVID-19 - Has femoral neck, total hip, or lumbar spine BMD T-score of = -1, OR has been or have a FRAX probability of fracture of greater than or equal to 20% for major osteoporotic fracture or 3% or greater for hip fracture.* - Individuals at high risk of fracture (i.e., risk in next 10 years is >20% according to FRAX) should be offered medication for osteoporosis. We will only include individuals at high risk of fracture who have declined medication or who had been on osteoporosis medication and decided to cease taking it in the appropriate timeline (as outlined by PI's and Physician). - Willing to participate in 2x weekly exercise sessions - Self-reported as postmenopausal for = 2 years, OR postmenopausal stats confirmed via blood test (female participants only) Exclusion Criteria: - Is unable to communicate in English - Has conditions affecting bone health - Takes or has taken medications affecting bone in the last 12 months or longer (as determined by the research team) - Has had a clinical or symptomatic spine fracture in the last 12 months, or a lower/upper limb fracture in the last 6 months - Has had a joint replacement in the last 6 months - Is receiving palliative care - Has major surgery planned in the next 12 months - Has had cancer within the last 2 years (excluding non-melanoma skin cancer) - Has planned travel time of greater than 6 weeks - Has been diagnosed with dementia - Is already participating in moderate- or high-intensity progressive resistance training = twice weekly - Weighs over 450 lbs - Has contraindications to resistance training |
Country | Name | City | State |
---|---|---|---|
Canada | University of Toronto | Markham | |
Canada | University of Saskatchewan | Saskatoon | |
Canada | University of Waterloo | Waterloo | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Waterloo | Canadian Institutes of Health Research (CIHR), University Health Network, Toronto, University of Saskatchewan |
Canada,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Dietary Intake | We will use Automated Self-Administered 24-hour dietary assessment tool (ASA24) to collect information on the participant's dietary intake through the self-administered 24-hour dietary record. Participants will report all food and beverage items and quantities on 3 days (2 weekday, 1 weekend day) at baseline, 6 months, and 12 months. We will also use the SCREEN2 tool at baseline only. We will report descriptive data on energy, protein, calcium, and vitamin D intake, and perform exploratory analyses of changes in these outcomes over time. We will perform subgroup analyses: 1) Baseline daily calcium (<1000 vs. >1000 mg per day); and 2) Baseline protein intake (<1.2g/kg body weight per day). We will explore changes in participants who are referred to a dietitian for counselling because of low intakes of protein, calcium, or vitamin D. | Baseline, 6 months, and 12 months | |
Primary | Lumbar Spine bone mineral density (BMD) | Lumbar spine (L1-L4) bone mineral density measured via dual-energy X-ray Absorptiometry (DXA) scan. | Baseline and 12 months | |
Secondary | Fractures | Composite outcome of new non-vertebral and vertebral fractures, and progression of existing vertebral fractures. We will report the number in each category separately. We will use a fracture questionnaire for non-vertebral fractures, and vertebral fractures that come to clinical attention. Participants will undergo a DXA scan for Vertebral Fracture Assessment (VFA) at baseline and the 12-months. A vertebral fracture will be defined as having a radiographic presence of =25% reduction in anterior, middle, or posterior vertebral height, verified by an experienced radiologist at University Health Network via the Genant visual semi-quantitative method. Baseline VFA will be assessed for vertebral fractures and compared to VFA at 12 months to ascertain if there has been progression of new fractures; progression will be defined as progression to a new Genant level or a change in height of at least 10%. | Over 12 months | |
Secondary | Rate of falls per person per year | Participants will be emailed a falls calendar via a survey at the end of each month. Participants will be asked to immediately report any falls to research assistant and to exercise physiologist. Exercise physiologists will report any noted falls to their study coordinator immediately and additional follow-up documentation will be required. Rate of falls and number of people who experience one or more falls will be compared between groups. | Over 12 months | |
Secondary | Number of people who experience one or more falls | Participants will be emailed a falls calendar via a survey at the end of each month. Participants will be asked to immediately report any falls to research assistant and to exercise physiologist. Exercise physiologists will report any noted falls to their study coordinator immediately and additional follow-up documentation will be required. Rate of falls and number of people who experience one or more falls will be compared between groups. | Over 12 months | |
Secondary | Bone-free lean mass | Whole body fat- and bone-free lean mass will be derived from DXA scans. | Baseline and 12 months | |
Secondary | Appendicular lean mass | We will calculate appendicular lean mass (kg) and its index (kg/m^2) from appendicular bone-free lean mass and height (cm). | Baseline and 12 months | |
Secondary | Height | Height will be a proxy measure of posture. | Baseline and 12 months | |
Secondary | Occiput-to-wall distance | Occiput-to-wall distance will be a proxy measure of posture. | Baseline and 12 months | |
Secondary | Knee extension peak torque | We will assess isometric knee extension peak torque using a knee extension test with a dynamometer. | Baseline, 6 months, and 12 months | |
Secondary | 30 Second Chair Stand Test. | We will use the 30 Second Chair Stand Test. | Baseline, 6 months, and 12 months | |
Secondary | Four Square Step Test | We will use the Four Square Step Test to assess lower extremity muscle power and dynamic balance during functional tasks. | Baseline, 6 months, and 12 months | |
Secondary | Grip Strength | We will assess grip strength of the non-dominant arm using a hand dynamometer. | Baseline, 6 months, and 12 months | |
Secondary | 10 Metre Walk Test. | We will assess gait speed using the 10 Metre Walk Test. | Baseline, 6 months, and 12 months | |
Secondary | 6 Minute Walk Test. | We will assess endurance using the 6 Minute Walk Test. | Baseline, 6 months, and 12 months | |
Secondary | Osteoporosis-specific quality of life (QUALEFFO-41) | We will use the QUALEFFO-41 as an osteoporosis specific measure of health-related quality of life. | Baseline, 6 months, and 12 months | |
Secondary | Quality of life (EQ5D5L) | We will use the EQ5D5L measure as a generic health-related quality of life measure. | Baseline, 6 months, and 12 months | |
Secondary | Serious adverse events | We will ask participants to report adverse events, using Health Canada definitions. We will report all serious and non-serious adverse events and identify those attributable to intervention. Safety outcomes will include all falls, fractures, and serious and non-serious adverse events. Any fractures or falls that are attributable to intervention will be considered under both fall or fracture outcomes, and harms. | Over 12 months | |
Secondary | Non-serious adverse events | We will ask participants to report adverse events, using Health Canada definitions. We will report all serious and non-serious adverse events and identify those attributable to intervention. Safety outcomes will include all falls, fractures, and serious and non-serious adverse events. Any fractures or falls that are attributable to intervention will be considered under both fall or fracture outcomes, and harms. | Over 12 months | |
Secondary | Glucose concentration | We will be taking a fasted blood sample from participants to measure plasma glucose concentrations using biochemical assay. Blood samples will only be collected from participants at the University of Waterloo site. | Baseline and 6 months | |
Secondary | Insulin concentration | We will be taking a fasted blood sample from participants to measure serum insulin concentrations using radioimmunoassay. Blood samples will only be collected from participants at the University of Waterloo site. | Baseline and 6 months | |
Secondary | Pro/anti-inflammatory markers | We will be taking a fasted blood sample from participants to measure plasma pro- and anti-inflammatory markers using a multiplex kit. Blood samples will only be collected from participants at the University of Waterloo site. | Baseline and 6 months | |
Secondary | Oxidative stress markers/antioxidant status (including oxygen radical absorbance capacity (ORAC) assay, protein carbonyls, glutathione peroxidase activity, thioredoxin, malondialdehyde) | We will be taking a fasted blood sample from participants to measure antioxidant status and markers of oxidative stress using commercially available assays. Blood samples will only be collected from participants at the University of Waterloo site. | Baseline and 6 months | |
Secondary | peptides synthesized and released by myocytes in muscle tissue | We will be taking fasting blood samples from participants to measure peptides synthesized and released by myocytes in muscle tissue via the Luminex Performance Assay. Blood samples will only be collected from participants at the University of Waterloo site. | Baseline and 6 months | |
Secondary | Total Hip BMD | Bone mineral density of the hip measured via DXA scans | Baseline and 12 months | |
Secondary | Femoral Neck BMD | Bone mineral density of the femoral neck measured via DXA scans | Baseline and 12 months | |
Secondary | Trabecular Bone Score | Trabecular bone score (TBS) will be calculated using TBS iNsight software. A high TBS value indicates high quality boner structure, whereas a low TBS value demonstrates a lower quality structure. The TBS index ranges from 0.9 - 1.6. | Baseline and 12 months | |
Secondary | Hip Geometry | We will use the DXA scanner's hip structural analysis feature to calculate estimates of hip geometry from proximal femur scans. | Baseline and 12 months | |
Secondary | Health Service Use | We will assess direct medical resources (e.g., tests, medications, hospitalization, rehabilitation), direct non-medical resources (e.g., out of pocket expenses, transportation), indirect resources (e.g., iMTA Productivity Cost Questionnaire) and clinical events and management. We will assess resource use for incident falls, fractures or adverse events. Multiplying resources collected by jurisdictional unit costs in Canadian dollars will determine the total cost per exercise program. | Baseline, 6 months, and 12 months | |
Secondary | Ratio of costs to QALY | We will calculate the ratio of incremental costs between the interventions, determined by trial resources, and clinical outcome (QALY) to achieve an incremental cost per life year gained outcome. | Baseline, 6 months, and 12 months | |
Secondary | Willingness to pay | We will assess willingness to pay for various exercise models using a contingent valuation survey. | Baseline, 6 months, and 12 months | |
Secondary | Body weight | Body weight in kg measured using scale | Baseline, 6 months and 12 months |
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