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Efficacy of tibolone and raloxifene for the maintenance of skeletal muscle strength, bone mineral density, balance, body composition cognitive function, mood/depression, anxiety and quality of life / well-being in late postmenopausal women > 70 years: Study design of a randomized, double-blind, double-dummy, placebo-controlled, single-center trial


- candidate number3020
- NTR NumberNTR1232
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jan-2008
- Secondary IDs02/163-E 
- Public TitleEfficacy of tibolone and raloxifene for the maintenance of skeletal muscle strength, bone mineral density, balance, body composition cognitive function, mood/depression, anxiety and quality of life / well-being in late postmenopausal women > 70 years: Study design of a randomized, double-blind, double-dummy, placebo-controlled, single-center trial
- Scientific TitleEfficacy of tibolone and raloxifene for the maintenance of skeletal muscle strength, bone mineral density, balance, body composition cognitive function, mood/depression, anxiety and quality of life / well-being in late postmenopausal women ˇÝ 70 years: Study design of a randomized, double-blind, double-dummy, placebo-controlled, single-center trial
- ACRONYMN/A
- hypothesisThe primary aim is to determine if there is a difference between tibolone and placebo or if there is a difference between raloxifene and placebo. The secondary aim is to determine if there is a difference between tibolone and raloxifene. Primary endpoints are muscle strength and bone mineral density. The secondary endpoints are postural balance, body composition, cognitive function, anxiety, mood and quality of life
- Healt Condition(s) or Problem(s) studiedQuality of life, Bone mineral density (BMD), Cognition, Muscle strength, Body composition, Tibolone, Raloxifene
- Inclusion criteria1. Healthy postmenopausal women
2. Minimum age 70 years at the time of inclusion
3. Body mass index between 18 and 35 kg/m2
4. Subjects should be willing and able to comply with the protocol for the duration of the study, after written informed consent
- Exclusion criteria1. Steroid therapy or other drugs affecting muscle mass taken during the last 6 months
2. History or presence of any malignancy (except non-melanoma skin cancers)
3. Undiagnosed abnormal vaginal bleeding in the past year prior to screening
4. Presence or history of endometrial hyperplasia with or without atypia
5. Presence or history of cardiovascular, cerebrovascular or thrombo-embolic disorders
6. Current liver or renal disease or history of this condition
7. Uncontrolled hypertension (systolic blood pressure > 170 mm Hg systolic and/or diastolic blood pressure >105 mm Hg)
8. Osteoporosis: Z-score < -2
9. Bone disease other than osteoporosis such as Paget's disease
10. Osteomalacia or bone metastases
11. Alcohol abuse (average intake of more than 4 alcohol containing units per day)
12. Smoking more than 10 cigarettes/day
13. Use of sex hormones, corticosteroids, insulin, anti-coagulants or enzyme-inducing drugs
14. Treatment with tibolone or raloxifene within the last 6 months
15. Known hypersensitivity to tibolone or raloxifene
16. Presence of any condition, concomitant disease, intercurrent illness or resultant therapy that would interfere either with the participants's compliance or with the results of the study and/or their evaluation
17. Major problems with locomotion and cognitive impairment (MMSE <24)
18. Participation in another study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 15-jul-2003
- planned closingdate1-jun-2008
- Target number of participants324
- InterventionsMuscle power and muscle strength:
- Maximum voluntary isometric knee extension strength (both legs) was measured as the force applied at the ankle, with the subject seated in an adjustable straight-back chair, the lower leg unsupported and the knee flexed to 90 degree. Force was measured with a strain gauge and recorded with a strain meter. Explosive leg extensor power (both legs) was assessed with the Nottingham Power Rig.
Handgrip strength (both hands), which is associated with general muscle strength, was measured with a handgrip mechanical dynamometer.

Bone mineral density (BMD):
BMD, measured by DEXA, was measured at the lumbar vertebrae (L1-L4, calculated from the total bone mineral content and the total area of the four lumbar vertebrae) and at the hip (neck, trochanter, and intertrochanteric region). (0 and 24 months)

The following secondary parameters were used to determine the effect of the study medication:
Functional mobility was assessed quantitatively with the timed 'get up & go' - test.
Postural balance was assessed by means of an analysis of body sway and by the functional reach test. Body sway was assessed with both eyes open and both eyes closed. In the Functional Reach the maximal push is recorded in cm. Endurance was measured with the 6-minute walking test. (modified Cooper test). Body composition was measured by bio-electrical impedance analysis (BIA) and by DEXA.

Quality of life, well-being and mood/depression:
- Quality of life was measured with the Women's Health Questionnaire (WHQ) and the EQ-5D questionnaire. The EuroQol (EQ-5D) questionnaire was developed by a European group as a standard non-disease-specific instrument for describing and valuing quality of life (EuroQol, Kind).
- Mood/depression was measured with the Geriatric Depression Scale (GDS).
- Anxiety was measured with the Dutch Version of the State-Trait Anxiety Inventory (Self-Judgment Questionnaire = STAI-DY). The STAI was specifically designed to be self-administered.

Cognitive function (15 Words test; Trails B test):
Cognitive function was assessed with the Groningen 15 Words test and the Trails B test. The Groningen 15 Words test is an improved version of a test originally devised by Rey.
- Primary outcomePrimary endpoints are muscle strength and bone mineral density.
- Secondary outcomeThe secondary endpoints are postural balance, body composition, cognitive function, anxiety, mood and quality of life.
- Timepoints0, 3 months, 6 months, 12 months, 24 months, 30 month (one month=28 days)
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. D.E. Jacobsen
- CONTACT for SCIENTIFIC QUERIESDr. D.E. Jacobsen
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Geriatric Medicine, Mobility Laboratory
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryBackground
Postmenopausal women are prone to develop functional disabilities as a result of reduction in muscle strength and muscle mass caused by diminished levels of female sex hormones. While hormone replacement therapy may counteract these changes, conventional hormone replacement therapy is associated with potential harmful effects, such as an increased risk of breast cancer, and its prescription is not recommended. For this reason newer alternative drugs, such as tibolone, a synthetic steroid with estrogenic, progestogenic and androgenic activity, and raloxifene, a selective estrogen receptor modulator, may be more appropriate. This trial investigates the effect of tibolone and raloxifene on muscle strength. Methods We recruited 318 elderly women in our single-center randomized, double-blind, double-dummy, placebo-controlled trial. Participants were randomized to tibolone 1.25 mg (Org OD 14, Organon NV, the Netherlands) plus placebo, raloxifene 60 mg (Evista®, Eli Lilly, United States) plus placebo or two placebo tablets daily for 24 months. 283 women started. The primary aim is to determine if there is a difference between tibolone and placebo or if there is a difference between raloxifene and placebo. Primary endpoints are muscle strength and bone mineral density. The secondary endpoints are postural balance, body composition, cognitive function, anxiety, mood and quality of life. The secondary aim is to determine if there is a difference between tibolone and raloxifene. The measure of effect is the change from the baseline visit to the visits after 3 months, 6 months, 12 months, and 24 months. A follow-up measurement is planned at 30 months to determine whether any effects are sustained after cessation of the study.
- Main changes (audit trail)
- RECORD18-jan-2008 - 9-mei-2010


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