Status:
TERMINATED
Menopause Osteoporosis and Bone Intervention Using Lifestyle Exercise.
Lead Sponsor:
Staffordshire University
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief Summary
Aim: to examine the effect of an exercise intervention for preventing osteoporosis among postmenopausal women. Objectives: To examine whether mean values for Broadband Ultrasound Attenuation (BUA) u...
Detailed Description
Data will be collected at baseline, on study completion and at 3-month follow-up. Sequel to baseline data collection and ascertainment of eligibility, participants will be randomised into either the e...
Eligibility Criteria
Inclusion
- postmenopausal; aged ≥50 years
Exclusion
- Volunteers will be excluded from the study if they: are using any medicated that may affect bone turnover (e.g., corticosteroids, anticonvulsants, anticoagulants, calcitonin, bisphosphonates, raloxifene, denosumab and/or anabolic agents such as parathyroid hormone and growth hormone or steroids), including hormone replacement therapy and hormone-based contraception, within 6 months of starting the study; have or have had any bone, metabolic, kidney, liver, thyroid, gastro-intestinal or hormonal disorders or cancer, that may affect bone turnover; have a close family history of osteoporosis; have sustained a low trauma fragility fracture in the past 6 months; are a heavy smoking (\>20 cigarettes/day); if they are already undertaking bone-specific jumping exercises or equivalent exercises; if they have an existing knee, hip or back injury or have any medical condition that would prevent them from completing the exercise. Additional exclusions at baseline testing will include: a low BUA score, i.e., estimated T score of \<2.5; obesity as determined by body mass index of \>35 km/m2, to minimise risk of strain or injury associated with the exercise. Participants will also not be able to undertake the bone scan if they have any foot swelling, as this can make results difficult to interpret.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2020
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04469374
Start Date
December 1 2019
End Date
December 20 2020
Last Update
October 25 2022
Active Locations (1)
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1
Staffordshire University
Stoke, England, United Kingdom, ST4 2DF