Effect of Physical Activity in Women With Manifest Osteporosis

The Effect of Physical Activity on Physical Function, Falls and Bone Geometry - a Randomized Control Trial in Women With Manifest Osteoporosis

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.

Study Overview

• Status: Withdrawn
• Conditions: Osteoporosis
• Intervention / Treatment: Behavioral: Weight bearing aerobic exercise

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 70-80 years of age
• manifest osteoporosis, BMD T-score ≤2.5 SD at the lumbar spine and/or hip
• female
• walk without walking aid

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Lifestyle counseling
Experimental: Weight bearing aerobic exercise	Behavioral: Weight bearing aerobic exercise; Weight bearing aerobic exercise three times per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Propensity to fall	Frequency of falls during time of intervention.	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Anticipated): June 10, 2012
• Primary Completion (Anticipated): June 10, 2012
• Study Completion (Actual): June 10, 2012

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: VGFOUREG-81091

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No