Bone Health in Postmenopausal Women: The Effect of Exercise With or Without Medication for Osteoporosis

NCT07267325 | Not Yet Recruiting

• 1 other identifier: 354429
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoporosis is a systemic bone disorder characterised by a reduced bone mass and structural deterioration, increasing the risk of fragility fractures, particularly in women post-menopause. Bone mass and structure can be assessed by scans. Antiresorptive medications are commonly prescribed to reduce bone resorption, preventing further bone loss and thus reducing the possibility of fracture. Exercise can also benefit bone mass and structure but current evidence do not show whether exercise is more, or less, effective in combination with antiresorptive medication. This study will compare the effect of a brief, home-based exercise programme on bone mineral and structural properties in women taking/ not taking antiresorptive medication.

Conditions

Osteoporosis in Post-menopausal Women

Keywords

Exercise; Bone mineral density; Bone strength; Bone geometry; Fracture risk; Bone structure; Biomarkers

Outcome Measures

Primary Outcomes (2)

• Femoral neck bone mineral content BMC

  (g) measured by DXA

  Baseline, 6 months and 12 months

• Femoral neck bone mineral density BMD

  (g/cm\^2) measured by DXA

  Baseline, 6 months and 12 months

Secondary Outcomes (43)

• Total hip bone mineral content BMC

  Baseline, 6 months and 12 months

• Total hip bone mineral density BMD

  Baseline, 6 months and 12 months

• Lumbar spine bone mineral content BMC

  Baseline, 6 months and 12 months

• Lumbar spine bone mineral density BMD

  Baseline, 6 months and 12 months

• Prevalent vertebral fracture

  Baseline, 6 months and 12 months

Study Arms (2)

Without any medication affecting bone

EXPERIMENTAL

Participants in this arm are postmenopausal women with low bone density who are not taking any bone medication for at least 12 months. They will participate in a 12-month supervised high impact unilateral hopping exercise.

Behavioral: EXERCISE TRAINING

With osteoporosis medication (antiresorptive )

EXPERIMENTAL

Participants in this arm are postmenopausal women with low bone density who are taking antiresorptive medication for at least 12 months. They will participate in a 12-month supervised high impact unilateral hopping exercise.

Behavioral: EXERCISE TRAINING; Drug: Antiresorptive medication (routine clinical care)

Interventions

EXERCISE TRAINING BEHAVIORAL

The unilateral high-impact (hopping) exercise will be on one randomly allocated exercise leg, with the contralateral leg being untrained to provide a control leg. Each session will begin with a warm-up targeting the legs and lower back. The progressive exercise regimen consists of multidirectional hopping exercises that will gradually increase in technique, intensity, and frequency to ensure safety. It will be personalised according to the participants' physical abilities and responses during or after the exercise.

With osteoporosis medication (antiresorptive ); Without any medication affecting bone

Antiresorptive medication (routine clinical care) DRUG

Participants in this arm are already taking prescribed antiresorptive medication as part of standard clinical care. The study will not provide or modify the medication.

With osteoporosis medication (antiresorptive )

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 55-75 years old
• \>4y since menopause/hysterectomy/oophorectomy.
• Baseline femoral neck or lumber spine BMD T-score between -1 and -3.
• Able to complete the hopping exercises.
• Have no regular involvement for more than once/week in:
• Strength, powerlifting or high load resistance exercise.
• High to moderate impact exercise that known to involve ground reaction forces 2 to 4 times greater than body weight (e.g. Jogging).
• Treatment group: taking antiresorptive treatment for osteoporosis continuously for at least 12 months, and who intend to continue this medication for the rest of the study.
• Control group: not taking any medication affecting bone and no intention to commence such medication for the rest of the study.

You may not qualify if:

• Body mass index (BMI) \>35 kg/m2
• Any medical condition, surgery, or injuries that contraindicate exercises including lower limb or back pain, knee or hip osteoarthritis.
• Vertebral fracture or multiple low trauma fractures (recent expert consensus recommends lower impact exercise for these groups)
• Replacement of hip joint(s)

Sponsors & Collaborators

• Loughborough University: lead
• University of Sheffield: collaborator
• University of Cambridge: collaborator

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Katherine Brooke-Wavell, Professor

  Loughborough University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nora Alohaly, PhD

CONTACT

+441509226207; n.alohaly@lboro.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The researcher conducting imaging assessments and analyses will remain blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 5, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)