None listed
Conditions
Brief summary
Reduced bone strength and increased fracture risk (osteoporosis) affects millions of older Australians, particularly women after menopause, resulting in massive burdens to society. Innovative research is desperately needed to address this. Exercise improves bone health however effects of combining exercise with bone-building medication are unknown and may lead to more effective collaborative treatment of osteoporosis. We are conducting a study in postmenopausal women with osteoporosis to determine whether a bone-building exercise programme can enhance effects of bone-building medication to improve bone mass over an 8-month period. We will assess whether 8-months combined osteoporosis drug therapy (romosozumab) with high-intensity exercise produces greater improvements in lumbar (lower) spine density compared to drug treatment with low-intensity exercise. The results will help determine whether doctors should prescribe bone-building exercise with drug therapy to enhance effectiveness of treatment in this priority population. This is the first randomised controlled trial initiating and combining drug and exercise treatment for osteoporosis and will provide important insights into the role of exercise in osteoporosis treatment. We will also assess whether romosozumab can improve muscle mass, strength and physical function compared to placebo, which may lead to reduction in falls which is important for people with osteoporosis given majority of fractures occur from falls. We expect that the combination of drug and exercise treatment will be the most effective strategy for improving lumbar spine bone density and that the drug will improve muscle mass, strength and physical function compared to placebo.
Interventions
Group 1: Drug intervention + Exercise intervention
Group 2: Drug intervention + Exercise control
Drug intervention: 210mg subcutaneous romosozumab injections monthly for 8-months, administered by healthcare professional and adherence reviewed based on study records.
Exercise intervention: HiRIT (high intensity resistance and impact training) - 45-minute sessions twice weekly for 8-months supervised by licenced exercise physiologists or physiotherapists at established exercise facilities. Ther
Group 1: Drug intervention + Exercise intervention Group 2: Drug intervention + Exercise control Drug intervention: 210mg subcutaneous romosozumab injections monthly for 8-months, administered by healthcare professional and adherence reviewed based on study records. Exercise intervention: HiRIT (high intensity resistance and impact training) - 45-minute sessions twice weekly for 8-months supervised by licenced exercise physiologists or physiotherapists at established exercise facilities. There will be a maximum of 8 participants per group. Adherence to the intervention will be monitored using session attendance logbooks. Exercises will include deadlift, squat, overhead press and jumping exercises. Exercise intensity is assessed using the subjective assessment 'reps in reserve'.
Sponsors
Royal North Shore Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
- Postmenopausal women aged between 50 years old and 80 years old (inclusive) - At least 2 years since menopause - Baseline DXA BMD T-score at lumbar spine, total hip or femoral neck between -1.5 and -3.5 in women aged younger than 70 years old - Baseline DXA BMD T-score at lumbar spine, total hip or femoral neck between -1.5 and -2.5 in women aged 70 years and older
Exclusion criteria
- Use of recent osteoporosis pharmacotherapy - Any baseline DXA BMD T-score at lumbar spine, total hip or femoral neck less than -3.5 SD in women aged younger than 70 years old - Any baseline DXA BMD T-score at lumbar spine, total hip or femoral neck less than -2.5 SD in women aged 70 years and older - Prior fragility fracture after the age of 50 years - Regular use of glucocorticoids at equivalent dose of 5mg prednisone per day or more - Active untreated secondary osteoporosis - Untreated vitamin D deficiency or hypocalcaemia - eGFR <30 - Any prior history of coronary artery/cerebrovascular event - Active malignancy other than non-melanoma skin cancer or ductal carcinoma in-situ - Already participating in resistance/high impact exercise at least once per week - Unable to ambulate independently without aids - Any contraindication to being able to participate in an exercise program - Planned leave for at least 4 weeks total (or at least 3 weeks continuous) during the 8-month study period - Non-fluent in speaking and understanding English
Outcome results
None listed