Bone and muscle structure and function in relation to exercise and oestrogen replacement

Completed

• Conditions: Osteopenia, sarcopenia; Musculoskeletal Diseases; Other disorders of bone density and structure

• Registration Number: ISRCTN49902272
• Lead Sponsor: niversity of Jyvaskyla (Finland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1. No serious medical conditions
2. No current or previous use of medications including oestrogen, fluoride, calcitonin, biophosphonates or steroids
3. Last menstruation at least 0.5 years but not more than 5 years ago
4. Follicle-stimulating hormone leves greater than 30 iu/litre
5. No contra-indications for exercise and HRT
6. Aged 50 - 57, caucasian post-menopausal women

Exclusion Criteria

1. Serious medical conditions
2. Current or previous use of medications including oestrogen, fluoride, calcitonin, biophosphonates or steroids
3. Currently menstruating or having last menstruation within 0.5 years of the onset of study or longer than 5 years ago
4. Follicle-stimulating hormone leves less than 30 iu/litre
5. Contra-indications for exercise and HRT

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Developing methods for the testing of material and structural changes in the trabecular and cortical bone sites of the lower leg in relation to high-impact exercise and hormone replacement:<br>1.1. Single photon absorption method<br>1.2. Computed tomography<br>1.3. Elastic wave propagation<br>1.4. Ultrasonography<br>2. The effects of a high-intensity, explosive-type physical training and hormonal replacement on lower leg muscle mass, structure and performance in post-menopausal women:<br>2.1. Ultrasonography<br>2.2. Computed tomography<br>2.3. Muscle biopsies<br>2.4. Maximal isometric strength measurements with dynamometer chair<br>2.5. Measurement of explosive muscle power; ability to elevate the body's centre of gravity during vertical jumps onto a contact mat<br>2.6. Muscle performance; maximal running speed over 20 m distance<br><br>All measurements were done at baseline (0 months), at mid-point (6 months) and after completion of the treatments (12 months).

Secondary Outcome Measures

Name	Time	Method
1. Examining the molecular mechanism responding to high-intensity, explosive-type physical training and hormonal replacement by using muscle biopsies, taken at baseline, after 0.5 years of study onset and after 1 year of study onset, by microarray and other applicable molecular methods<br>2. Examining the adaptation of bone collagen metabolism and the different types of muscle fibres to altered force transmission and oestrogen status (using serum and urine samples to determine the content of deoxypyridinoline in overnight (10 hour) samples and using immunohistochemical methods with respective antibodies<br><br>All measurements were done at baseline (0 months), at mid-point (6 months) and after completion of the treatments (12 months).