Effects of Continuous Combined Hormone Replacement Therapy and Clodronate on Bone Mineral Density (BMD) in Osteoporotic Women (Osteo)
|ClinicalTrials.gov Identifier: NCT00877097|
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : April 7, 2009
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.
|Condition or disease||Intervention/treatment|
|Osteoporosis||Drug: Klodronate and Kliogest Procedure: Placebo+ Kliogest Drug: Bonefos|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||167 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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.|
|Study Start Date :||July 1996|
|Primary Completion Date :||December 2002|
|Study Completion Date :||February 2009|
Clodronate 800 mg / day + estradiol 2 mg + norethisterone acetate 1 mg / day for five years.
|Drug: Klodronate and Kliogest|
Placebo Comparator: 2
Placebo 2 tablets/ day + estradiol 2 mg + norethisterone acetate 1 mg / day for five years.
|Procedure: Placebo+ Kliogest|
Active Comparator: 3
Clodronate 800 mg / day for five years.
- BMD once a year [ Time Frame: 1996-2002 ]
- bone markers once a year [ Time Frame: 1996-2002 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877097
|Principal Investigator:||Marjo T Tuppurainen, MD, PhD||Dept. of Obstetrics and Gynecology, Kuopio University Hospital|