Osteoporosis Clinical Trial
Official title:
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.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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