Effect of Physical Activity in Women With Manifest Osteporosis

NCT04768712 | Withdrawn

• 1 other identifier: VGFOUREG-81091
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives: To investigate if a physical activity intervention (one year) can reduce the risk of falls (primary endpoint), improve physical function (balance and muscle strength) and cortical bone geometry as well as trabecular microarchitecture (secondary endpoints) in women, 70-80 years old, with manifest osteoporosis, treated with zoledronic acid, calcium and vitamin D. Strategic goal: To include 200 patients (100 intervention and 100 controls) during 2010 and 2011 and randomize 100 patients to a one year physical activity intervention (3 hours weekly). The results will be published in an international scientific peer-review journal. All patients will receive standard medical treatment with calcium, vitamin D and yearly zoledronic acid. Study rationale: The role of physical activity intervention has not previously been evaluated in patients with manifest osteoporosis and zoledronic acid treatment. Methodology: Randomized controlled trial. All included patients (women 70-80 years of age) will have manifest osteoporosis, be treatment naïve, and will be treated on clinical indication with yearly infusions of zoledronic acid (approved treatment, for this patient category, by the Swedish Medical Products Agency). Patients with secondary osteoporosis, with disabilities, and with high levels of exercise at the baseline visit will be excluded. Intention to treat analysis will be used. Physical activity intervention includes 3 hours of weight bearing aerobic exercise per week, using a standardized program. Patients in both groups will be contacted monthly and asked about their exercise habits. Frequency of falls, physical activity level will be ascertained using questionnaires. Balance and muscle strength will be assessed using standardized tests. Bone geometry at the tibia diaphysis will be determined using an XCT2000 pQCT device (Stratec, Germany) and trabecular microarchitecture at the tibia metaphysis will be determined using an XtremeCT device (Scanco Medical AG, Switzerland). These examinations will be performed on all patients prior to the intervention and after the completion of the study.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Propensity to fall

  Frequency of falls during time of intervention.

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Physical function (Balance and muscle strength)

  Prior to the intervention and after the completion (an average of 1 year) of the study

• Trabecular microarchitecture

  Prior to the intervention and after the completion (an average of 1 year) of the study

• Cortical bone geometry

  Prior to the intervention and after the completion (an average of 1 year) of the study

Study Arms (2)

Weight bearing aerobic exercise

EXPERIMENTAL

Behavioral: Weight bearing aerobic exercise

Lifestyle counseling

NO INTERVENTION

Interventions

Weight bearing aerobic exercise BEHAVIORAL

Weight bearing aerobic exercise three times per week.

Weight bearing aerobic exercise

Eligibility Criteria

• Age: 70 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age
• manifest osteoporosis, BMD T-score ≤2.5 SD at the lumbar spine and/or hip
• female
• walk without walking aid

You may not qualify if:

• male
• high level of exercise, ≥2 times/week, at baseline
• secondary osteoporosis
• previous treatment with bisphosphonate or other osteoporosis induced medicine

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Consultant

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 24, 2021
• Study Start: June 10, 2012
• Primary Completion: June 10, 2012
• Study Completion: June 10, 2012
• Last Updated: February 24, 2021

Record last verified: 2021-02