Effects of Continuous Combined Hormone Replacement Therapy and Clodronate on Bone Mineral Density (BMD) in Osteoporotic Women (Osteo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00877097
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : April 7, 2009
Information provided by:
Kuopio University Hospital

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Klodronate and Kliogest Procedure: Placebo+ Kliogest Drug: Bonefos Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Primary Completion Date : December 2002
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
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.
Drug: Bonefos

Primary Outcome Measures :
  1. BMD once a year [ Time Frame: 1996-2002 ]

Secondary Outcome Measures :
  1. bone markers once a year [ Time Frame: 1996-2002 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Postmenopausal
  • BMD T-score <-2.5sd

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00877097

Sponsors and Collaborators
Kuopio University Hospital
Principal Investigator: Marjo T Tuppurainen, MD, PhD Dept. of Obstetrics and Gynecology, Kuopio University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mari Ollikainen, Kuopio University Hospital Identifier: NCT00877097     History of Changes
Other Study ID Numbers: KUH5302410
Compliance 1x/year x5
BP 1x/year 5 yrs
endometrial sample 1x/yearx5
adverse effects 1x/year x5
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: April 7, 2009
Last Verified: April 2009

Keywords provided by Kuopio University Hospital:
Bone mineral density

Additional relevant MeSH terms:
Contraceptive Agents, Female
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Clodronic Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Bone Density Conservation Agents
Contraceptives, Oral
Contraceptives, Oral, Synthetic