Combining bone-building medication with bone-building exercise in postmenopausal women with low bone mass

Phase 4

• Conditions: osteopenia; osteoporosis; Musculoskeletal - Osteoporosis; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12623000867695
• Lead Sponsor: Royal North Shore Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-14
• Last Update Posted: 29 January 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

Postmenopausal women aged between 50 years old and 80 years old
- At least 5 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 or equal to -3.5 in women aged younger than 70 years old
- Any baseline DXA BMD T-score at lumbar spine, total hip or femoral neck less than or equal to -2.5 in women aged 70 years and older
- Prior fragility fracture
- 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
- Coronary artery/cerebrovascular event within the last 12 months
- High cardiovascular risk (greater than or equal to 15% 5-year cardiovascular event risk)
- Active malignancy
- Already participating in resistance/high impact exercise
- Unable to ambulate independently without aids
- Non-fluent in speaking and understanding English
- Deemed medically unsafe to commence HiRIT exercise intervention

Study & Design

• Study Type: Interventional
• Study Design: Not specified