Effects of Continuous Combined Hormone Replacement Therapy and Clodronate on Bone Mineral Density (BMD) in Osteoporotic Women
Osteo
Randomized Clinical Trial on the Effectts of Estradiol 2 mg + NETA 1 mg With or Without Clodronate on Bone Mineral Density and Bone Markers of Osteoporotic Postmenopausal 167 Finnish Women.
5 other identifiers
interventional
167
0 countries
N/A
Brief Summary
Recent studies suggest that the combination of two inhibitors of bone resorption may induce a greater increase in bone mineral density (BMD) than either agent alone. In this 5-year partly randomized study the investigators examined the effects of hormone therapy (HT) with or without bisphosphonate on BMD on osteoporotic women. In the Kuopio Osteoporosis Study (OSTPRE) a population based sample of 3200 women were selected for BMD measurement by Lunar DPX in 1995-1997. In all 167 women aged 61±2.7 years (11±4.9 years postmenopausal), and the T-score \< -2.5 SD at either the lumbar spine or femoral neck were recruited for this sub-study. They received daily estradiol hemihydrate (E2) 2mg + norethisterone acetate (NETA) 1mg (Kliogest®, Novo Nordisk, Denmark) and were randomized to get additional Boneplac, which consisted of either 800mg clodronate (Bonefos®, Leiras Ltd, Finland) (n=55, KB-group) or placebo (n=55, K-group). In case of contraindications or refusal from HT, the women were offered clodronate 800 mg/day (n=57, B-group) to be taken to empty stomach with a glass of water 30 minutes to two hours before breakfast. BMD was measured at time intervals 0, 1, 3 and 5-years. All repeated BMD values were interviewed by one investigator and primarily the vertebrae L2-L4 were followed. In case of spinal deformities during the study (38.3%) other lumbar levels were followed. The baseline BMD values (lumbar spine BMD 0.839±0.072 g/cm², femoral neck BMD 0.759±0.094g/cm²) were similar between the groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 1996
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1996
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 2, 2009
CompletedFirst Posted
Study publicly available on registry
April 7, 2009
CompletedApril 7, 2009
April 1, 2009
6.4 years
April 2, 2009
April 6, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BMD once a year
1996-2002
Secondary Outcomes (1)
bone markers once a year
1996-2002
Study Arms (3)
1
EXPERIMENTALClodronate 800 mg / day + estradiol 2 mg + norethisterone acetate 1 mg / day for five years.
2
PLACEBO COMPARATORPlacebo 2 tablets/ day + estradiol 2 mg + norethisterone acetate 1 mg / day for five years.
3
ACTIVE COMPARATORClodronate 800 mg / day for five years.
Interventions
Eligibility Criteria
You may qualify if:
- Postmenopausal
- BMD T-score \<-2.5sd
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Tuppurainen M, Harma K, Komulainen M, Kiviniemi V, Kroger H, Honkanen R, Alhava E, Jurvelin J, Saarikoski S. Effects of continuous combined hormone replacement therapy and clodronate on bone mineral density in osteoporotic postmenopausal women: a 5-year follow-up. Maturitas. 2010 Aug;66(4):423-30. doi: 10.1016/j.maturitas.2010.04.013. Epub 2010 May 23.
PMID: 20547017DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marjo T Tuppurainen, MD, PhD
Dept. of Obstetrics and Gynecology, Kuopio University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 2, 2009
First Posted
April 7, 2009
Study Start
July 1, 1996
Primary Completion
December 1, 2002
Study Completion
February 1, 2009
Last Updated
April 7, 2009
Record last verified: 2009-04