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

ISRCTN ISRCTN49902272
DOI https://doi.org/10.1186/ISRCTN49902272
Secondary identifying numbers N/A
Submission date
11/06/2009
Registration date
09/07/2009
Last edited
09/07/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Harri Suominen
Scientific

PO Box 35
Jyväskylä
40014
Finland

Study information

Study designRandomised double-blind placebo-controlled one-year-trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleBone and muscle structure and function in relation to exercise and oestrogen replacement: a randomised double-blind placebo-controlled one-year-trial
Study acronymEx/HRT-study
Study objectivesDeterioration of bone and muscle properties may occur after menopause. High-impact, power training and oestrogen-containing hormonal replacement therapy (HRT) may reverse these deteriorations. Combined treatments with both training and HRT may have additional effects.
Ethics approval(s)Ethical Committee of the Central Hospital of Central Finland has approved this study on 11th June 1996 (ref: Dnro1053/04/046/06). The study was re-evaluated concerning the use of DNA-samples and approved on the 18th October 2005.
Health condition(s) or problem(s) studiedOsteopenia, sarcopenia
InterventionExercise (Ex): 1-year progressive physical training programme that included a supervised circuit training session twice a week and a series of exercises at home 4 days per week. Training was high-impact power training consisting of circuit training periods for 8 - 11 weeks, interrupted by three high-impact aerobic dance periods for 2 weeks and a summer pause for 5 weeks. They also used placebo tablets.
HRT: the combined oestradiol (2 mg) and noretisterone acetate (1 mg) product (Kliogest®, Novo Nordisk) was administered continously, one tablet per day for one year. The administration of HRT was conducted double-blinded.
Ex+HRT: participants conducted the training program and used HRT.
CO: control arm participants did not recieve any treatment, but they used placebo and were asked not to change their daily physical activities.

Total duration of the treatment was 12 months; the 12-month measurements were performed within a week of ending the treatments. This part of the trial was completed on the 30th August 1997.

A 10-year follow-up measurement was also performed for the participants who were willing to come back to the lab (n = 47). These measurements were performed from the 15th September to 24th November 2007. End of analysis and follow-up will be on the 31st December 2013.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Oestradiol, noretisterone acetate (Kliogest®)
Primary outcome measure1. 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:
1.1. Single photon absorption method
1.2. Computed tomography
1.3. Elastic wave propagation
1.4. Ultrasonography
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:
2.1. Ultrasonography
2.2. Computed tomography
2.3. Muscle biopsies
2.4. Maximal isometric strength measurements with dynamometer chair
2.5. Measurement of explosive muscle power; ability to elevate the body's centre of gravity during vertical jumps onto a contact mat
2.6. Muscle performance; maximal running speed over 20 m distance

All measurements were done at baseline (0 months), at mid-point (6 months) and after completion of the treatments (12 months).
Secondary outcome measures1. 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
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

All measurements were done at baseline (0 months), at mid-point (6 months) and after completion of the treatments (12 months).
Overall study start date01/09/1996
Completion date31/12/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants80
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/09/1996
Date of final enrolment31/12/2013

Locations

Countries of recruitment

  • Finland

Study participating centre

PO Box 35
Jyväskylä
40014
Finland

Sponsor information

University of Jyvaskyla (Finland)
University/education

Department of Health Sciences
P.O.Box 35
Jyväskylä
FI-40014
Finland

Website http://www.jyu.fi/
ROR logo "ROR" https://ror.org/05n3dz165

Funders

Funder type

Government

Finnish Academy (Finland) - 1st January 1996 - 1st January 2001

No information available

Finnish Funding Agency for Technology and Innovation (TEKES) (Finland) - 1st January 1996 - 1st January 2001

No information available

Finnish Ministry of Education (Finland) (ref: 98/772/2002)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article ultrasound and bone mineral density assessment results 01/06/1999 Yes No
Results article developing methods for assessing changes in bone results 01/07/2000 Yes No
Results article initial results 01/08/2001 Yes No
Results article bone mass distribution results 01/07/2002 Yes No
Results article developing methods for testing the material changes and turnover in bone results 01/07/2002 Yes No
Results article lower-body muscle power results 01/06/2004 Yes No
Results article muscle attenuation results 01/09/2005 Yes No
Results article muscular transcriptome results 01/12/2007 Yes No