Search / Trial NCT00000430

Low-Dose Hormone Replacement Therapy and Alendronate for Osteoporosis

Launched by NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS) · Jan 18, 2000

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Trial Information

Current as of March 02, 2024

Terminated

Keywords

Osteoporosis Osteopenia Postmenopausal Women Hormone Replacement Therapy Alendronate

Description

Clinical trials of estrogen/progestin replacement therapy (HRT) and a bisphosphonate, alendronate (ALN), have demonstrated that both are effective in causing gains in bone mass and preventing bone loss and fractures in postmenopausal women. The FDA has approved both these drugs for prevention and treatment of fractures, and both are widely used in clinical practice. Because both are approved and effective, and they work by different mechanisms, many patients and their physicians ask whether both should be taken in combination, particularly in cases of severe disease. The question is asked f...

Gender

Female

Eligibility criteria

  • Inclusion Criteria:
  • Women at least 60 years of age.
  • Good general health.
  • Willingness to participate in this 3.5 year study.
  • Ability to give informed consent.
  • Ability to live independently and travel to the research center for visits (we will provide transportation on a limited basis).
  • Spine bone mineral density (BMD) (L1-4) T-score between -1.0 and -2.5, or a hip T-score between -1.0 and -2.5. A T-score of -1.0 is equal to a bone mass of one standard deviation below the mean peak bone mass in healthy young adult women.
  • Exclusion Criteria:
  • Any history of cancer except the following: (a) superficial basal or squamous cell carcinoma of the skin which has been completely resected or resolved by a topical chemotherapeutic agent, and (b) other malignancies treated curatively at least 10 years previously, without any evidence of recurrence.
  • Abnormal transvaginal ultrasound that has not been investigated and cleared by endometrial biopsy.
  • History of low-trauma hip or spine fracture previously diagnosed.
  • Serious residuals from cerebral vascular disease.
  • Diabetes mellitus, except for easily controlled, non-insulin dependent or insulin dependent diabetes mellitus without significant microvascular or neuropathic disease.
  • Serum creatinine >1.9 mg/dl.
  • Chronic liver disease or alcoholism.
  • Treatment with bone active agents such as fluoride or bisphosphonates within the previous 2 years.
  • Treatment with calcitonin, estrogen, or a selective estrogen receptor modulator within the previous 6 months.
  • Systemic corticosteroid therapy at pharmacologic levels for more than 6 months duration.
  • Any corticosteroid therapy within the previous 6 months.
  • Treatment with anticonvulsant therapy within the previous year.
  • Clinically significant abnormalities on pre-study laboratory or clinical screens.
  • Treatment with thyroid hormone is accepted, provided the patient is euthyroid at the time of entry, and the serum TSH by ultrasensitive assay is normal.
  • Uncontrolled hypertension.
  • Unstable angina.
  • Myocardial infarction within 1 year prior to entry.
  • Evidence of metabolic bone disease, e.g. hyper- or hypoparathyroidism, Paget's disease, osteomalacia, osteogenesis imperfecta, or others.
  • Active rheumatoid arthritis or collagen disease.
  • Recent major gastrointestinal disease (within the past year) such as peptic ulcer, malabsorption, chronic ulcerative colitis, regional enteritis, or any significant chronic diarrhea state.
  • Tobacco use at a level of more than 10 cigarettes per day.

Attachments

readout_NCT00000430_2024-03-02.pdf

4.5 MB

NCT00000430_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Omaha, Nebraska, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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