Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Osteoporosis: regulatory view.

S Sobel1

  • 1Division of Metabolism and Endocrine Drug Products, Center for Drugs and Biologics, Food and Drug Administration, Rockville, MD.

Public Health Reports (Washington, D.C. : 1974)
|July 1, 1987
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

The Process of Family Reconstruction after DNA Testing for Huntington Disease.

Journal of genetic counseling·2015
Same author

What your patients don't tell you.

American family physician·2000
Same author

Regulatory concerns at various phases of drug development.

The American journal of cardiology·1998
Same author

Incidence and correlates of tardive dyskinesia in first episode of schizophrenia.

Archives of general psychiatry·1996
Same author

Toxic shock and Down syndromes in a dental patient: a case report and review of the literature.

Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry·1994
Same author

Drugs commonly used by the elderly: a review for dental practice.

Journal of the California Dental Association·1994
Same journal

Experiential and Structural Determinants of Communicable Disease Reporting Among Health Care Providers in Alameda County, California.

Public health reports (Washington, D.C. : 1974)·2026
Same journal

A Case-Case Study of Sporadic and Outbreak-Associated Listeriosis Exposures: <i>Listeria</i> Initiative Food History Data, 2016-2022.

Public health reports (Washington, D.C. : 1974)·2026
Same journal

Developing a Prioritization Method for Imported Infectious Diseases Using National Notifiable Surveillance Data: The Tokyo 2020 Olympic and Paralympic Games Experience.

Public health reports (Washington, D.C. : 1974)·2026
Same journal

Reduction in Hepatitis C Virus RNA Positivity Among Clients in an Inpatient Substance Use Treatment Program in New York City.

Public health reports (Washington, D.C. : 1974)·2026
Same journal

Managing Institutional Change Through Participatory Planning: Creating the College of Integrated Health Sciences at the University at Albany, State University of New York.

Public health reports (Washington, D.C. : 1974)·2026
Same journal

An Urgent Need for Evidence-Based Guidance on Mercury Exposure Screening to Inform Public Health Policy, Practice, and Prevention.

Public health reports (Washington, D.C. : 1974)·2026
See all related articles

Evaluating osteoporosis drugs is challenging. The Food and Drug Administration (FDA) provides guidelines, with estrogen and calcitonin approved, while other treatments are under investigation.

Area of Science:

  • Pharmacology
  • Endocrinology
  • Bone Metabolism

Background:

  • Osteoporosis treatment and prevention drug evaluation presents significant challenges.
  • The Food and Drug Administration (FDA) has established guidelines for clinical drug investigations in this area.
  • Current approved treatments include estrogen for postmenopausal osteoporosis and calcitonin, each with specific considerations.

Purpose of the Study:

  • To review the current landscape of drug evaluation for osteoporosis.
  • To outline FDA guidelines for investigating osteoporosis drugs.
  • To discuss approved and investigational therapies for osteoporosis.

Main Methods:

  • Review of FDA guidelines for osteoporosis drug development.
  • Summary of approved osteoporosis medications (estrogen, calcitonin).

Related Experiment Videos

  • Overview of drugs currently under investigation for osteoporosis treatment.

    • Main Results:

    • Estrogen is approved for postmenopausal osteoporosis, requiring careful risk-benefit assessment and minimal effective dosage.
    • Calcitonin is approved but may be limited by parenteral administration, antibody formation, and cost.
    • Calcium, though recommended, lacks formal FDA drug evaluation for osteoporosis.
    • Several other drug classes, including anabolic steroids, fluorides, vitamin D, biphosphonates, parathyroid hormone, and thiazides, are under investigation.

    Conclusions:

    • Drug evaluation for osteoporosis requires adherence to FDA guidelines.
    • Approved therapies like estrogen and calcitonin have specific limitations and require individualized patient management.
    • Ongoing research into novel agents like biphosphonates and parathyroid hormone is crucial for advancing osteoporosis treatment.