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

This study has been completed.
Sponsor:
Information provided by:
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00877097
First received: April 2, 2009
Last updated: April 6, 2009
Last verified: April 2009
  Purpose

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 Intervention
Osteoporosis
Drug: Klodronate and Kliogest
Procedure: Placebo+ Kliogest
Drug: Bonefos

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • BMD once a year [ Time Frame: 1996-2002 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • bone markers once a year [ Time Frame: 1996-2002 ] [ Designated as safety issue: No ]

Enrollment: 167
Study Start Date: July 1996
Study Completion Date: February 2009
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal
  • BMD T-score <-2.5sd

Exclusion Criteria:

  • None
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00877097

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

No publications provided by Kuopio University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mari Ollikainen, Kuopio University Hospital
ClinicalTrials.gov 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
Study First Received: April 2, 2009
Last Updated: April 6, 2009
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Kuopio University Hospital:
osteoporosis
Bone mineral density
clodronate
HRT
postmenopausal

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Clodronic Acid
Trisequens
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014