Parathyroid Hormone (PTH) With Alendronate for Osteoporosis

ClinicalTrials.gov ID: NCT00005006

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Official title

Cyclical vs Daily Continuous PTH in Combination With Alendronate vs Alendronate Alone

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study investigates the effectiveness of parathyroid hormone (PTH) in combination with alendronate, a standard treatment for osteoporosis that blocks or reduces bone loss. We are using alendronate because it may help protect patients against any possible harmful effects of PTH in cortical bone such as the long bones or hip. We are testing two different treatment schedules of PTH-one in which we give PTH daily and one in which we give PTH for 3 out of every 6 months in a cyclical fashion. The entire study is 21 months long; the active treatment period is 18 months with a 6-month followup period. The main effects we will look for in this study are changes in body chemicals that are signs of bone formation or bone breakdown, and changes in bone density throughout the skeleton. We will randomly assign all study participants, who are women aged 50 and over, to either stay on alendronate alone, receive daily continuous PTH plus alendronate, or receive daily PTH for 3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily alendronate.

Study identification

NCT ID: NCT00005006
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Helen Hayes Hospital; Other
Enrollment: 140 participants

Conditions and interventions

Conditions

Osteoporosis

Interventions

Drug

Eligibility (public fields only)

Age range: 50 Years and older
Sex: Female
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 1987 (Type not available)
Primary completion: Feb 2003 (Actual)
Completion: Dec 2006 (Actual)
Last update posted: Aug 19, 2015

1987 – 2006

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Helen Hayes Hospital, Clinical Research Center	West Haverstraw	New York	10993	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00005006, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 19, 2015 · Synced Nov 15, 2026