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Sponsors and Collaborators: |
National Institute of Dental and Craniofacial Research (NIDCR) Washington University School of Medicine |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004650 |
OBJECTIVES: I. Quantify periodontal alveolar bone loss rates in postmenopausal women.
II. Evaluate the effects of estrogen on alveolar bone loss rates in these patients.
III. Determine whether changes in periodontal bone mass relate to bone mass changes in other skeletal sites in these patients.
Condition | Intervention | Phase |
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Osteoporosis |
Drug: conjugated estrogens Drug: Medroxyprogesterone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Efficacy Study |
Estimated Enrollment: | 150 |
Study Start Date: | August 1993 |
PROTOCOL OUTLINE: This is a randomized, double-blind, placebo controlled study. Patients are randomly assigned to receive placebo or conjugated estrogens and, if no prior hysterectomy, medroxyprogesterone. Patients also receive calcium supplementation therapy daily for 3 years. Participants in the placebo group may be removed from study if bone loss exceeds 5% per year.
A study duration of 3 years is anticipated.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
Study ID Numbers: | 199/11726, WUSM-900449 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004650 History of Changes |
Health Authority: | United States: Federal Government |
disease-related problem/condition osteoporosis rare disease |
Medroxyprogesterone 17-Acetate Estrogens Antineoplastic Agents, Hormonal Contraceptive Agents Hormone Antagonists Contraceptives, Oral Contraceptive Agents, Female Rare Diseases Hormones, Hormone Substitutes, and Hormone Antagonists |
Osteoporosis Alveolar Bone Loss Bone Diseases, Metabolic Contraceptive Agents, Male Bone Diseases Hormones Estrogens, Conjugated (USP) Musculoskeletal Diseases Medroxyprogesterone |
Estrogens Medroxyprogesterone 17-Acetate Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis Bone Diseases, Metabolic |
Reproductive Control Agents Contraceptive Agents, Male Bone Diseases Hormones Pharmacologic Actions Estrogens, Conjugated (USP) Musculoskeletal Diseases Therapeutic Uses Contraceptives, Oral, Synthetic Medroxyprogesterone |