Parathyroid Hormone (PTH) With Alendronate for Osteoporosis
Cyclical vs Daily Continuous PTH in Combination With Alendronate vs Alendronate Alone
3 other identifiers
interventional
140
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 1987
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1987
CompletedFirst Submitted
Initial submission to the registry
March 24, 2000
CompletedFirst Posted
Study publicly available on registry
March 27, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedAugust 19, 2015
August 1, 2015
15.4 years
March 24, 2000
August 17, 2015
Conditions
Keywords
Study Arms (3)
1
ACTIVE COMPARATORAlendronate alone
2
ACTIVE COMPARATORTeriparatide daily plus alendronate
3
ACTIVE COMPARATORTeriparatide cyclically plus alendronate
Interventions
Alendronate 70mg/week; Teriparatide 20mcg/ day
Eligibility Criteria
You may qualify if:
- Approximately 140 postmenopausal women, over 50, who have been on alendronate (at least 35 mg/week) for a period of at least 18 months.
- Lumbar spine or hip T-score at the time of recruitment must be equal to or below -2.5.
You may not qualify if:
- All subjects must have primary osteoporosis.
- Subjects cannot be on any other medications known to influence bone metabolism besides alendronate. Subjects can be on Synthroid if TSH is normal.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Helen Hayes Hospital, Clinical Research Center
West Haverstraw, New York, 10993, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Lindsay, MD
Helen Hayes Hospital
- PRINCIPAL INVESTIGATOR
Felicia Cosman, MD
Helen Hayes Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Clinical Medicine
Study Record Dates
First Submitted
March 24, 2000
First Posted
March 27, 2000
Study Start
September 1, 1987
Primary Completion
February 1, 2003
Study Completion
December 1, 2006
Last Updated
August 19, 2015
Record last verified: 2015-08