Search / Trial NCT00000427

Effects of Parathyroid Hormone in Men With Osteoporosis

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jan 18, 2000

Trial Information

Current as of November 14, 2024

Completed

Keywords

Parathyroid Hormone (Pth) Alendronate Bone Metabolism Bone Mineral Density (Bmd) Bone Loss Postmenopausal Osteoporosis Osteoporosis In Men

ClinConnect Summary

Osteoporosis causes bones to weaken and break more easily. Alendronate is used to treat or prevent osteoporosis. PTH is a protein hormone that increases the calcium and phosphorus release from bone, leading to formation of new bone. This study will examine the changes in bone density measured at multiple places in the skeleton and changes in chemicals in the body that indicate bone breakdown and bone formation. The study will indicate whether some breakdown of bone is required for PTH to have an overall bone-building effect in men.

Participants will be randomly assigned to receive PTH alon...

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • Bone density of the spine or femoral neck two standard deviations below the mean of young adult men
  • Normal renal and liver function tests, normal serum testosterone level, normal vitamin D and PTH levels
  • Exclusion Criteria:
  • Significant cardiac, renal, hepatic, or malignant disease.
  • Disorders (e.g., Paget's disease, hyperthyroidism, hyperparathyroidism) or drugs (e.g., steroids, anticonvulsants, lithium, bisphosphonates, calcitonin, fluoride) known to affect bone metabolism
  • Active peptic ulcer disease or severe reflux

Trial Officials

Joel S. Finkelstein, MD

Principal Investigator

Massachusetts General Hospital

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Boston, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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