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 design	Randomised double-blind placebo-controlled one-year-trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Bone and muscle structure and function in relation to exercise and oestrogen replacement: a randomised double-blind placebo-controlled one-year-trial
Study acronym	Ex/HRT-study
Study objectives	Deterioration 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) studied	Osteopenia, sarcopenia
Intervention	Exercise (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 type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Oestradiol, noretisterone acetate (Kliogest®)
Primary outcome measure	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: 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 measures	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 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 date	01/09/1996
Completion date	31/12/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	80
Key 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
Key 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
Date of first enrolment	01/09/1996
Date of final enrolment	31/12/2013

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"	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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	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