Search / Trial NCT00000400

Alendronate and/or Parathyroid Hormone for Osteoporosis

Launched by MASSACHUSETTS GENERAL HOSPITAL · Nov 3, 1999

Trial Information

Current as of December 26, 2024

Completed

Keywords

Osteoporosis Bone Formation Bone Resorption Parathyroid Hormone (Pth) Postmenopause

ClinConnect Summary

This is a randomized, prospective, open-label study in which osteoporotic postmenopausal women self-administer synthetic hPTH-(1-34), alendronate, or both, every day for 2.5 years. Participants initially come to Massachusetts General Hospital once a month, and subsequently once every 3-6 months, for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass. One-third of the participants take hPTH-(1-34) daily, one-third take alendronate once daily, and one-third take both daily (Phase A, months 0-30).

Par...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Lumbar spine or hip BMD T-score less than or equal to minus 2.0
  • Postmenopausal at least 5 years
  • Fully ambulatory
  • Able to give informed consent
  • Exclusion Criteria:
  • No concurrent illnesses that cause bone loss
  • No recent drug treatment for osteoporosis
  • No recent fracture

Trial Officials

Robert M. Neer, 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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