NCT00018447

Brief Summary

This study is designed to determine if combining parathyroid (PTH 1-34) with fluoride (MFPSR) therapy in a cyclic treatment regimen will: (1) produce a greater increase in bone density of the spine than would be produced by either treatment alone; (2) prevent the resistance (i.e., decreased bone formation and no further increase in bone density) that is observed within 18-24 months of PTH therapy; (3) eliminate the calcium deficiency and osteomalacia that can occur with fluoride; (4) prevent excessive bone fluoride content; and (5) result in an increase in bone density which is maintained after treatment is discontinued.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 1998

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1998

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2001

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
Last Updated

January 21, 2009

Status Verified

December 1, 2004

First QC Date

July 3, 2001

Last Update Submit

January 20, 2009

Conditions

Osteoporosis, Post-Menopausal

Keywords

osteoporosis

Interventions

PTH 1-34DRUG
MFPSR-fluorideDRUG

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • More than 1 vertebral fracture in lumbar spine or more than 4 fracture in the T-L spine.
  • Weight less than 45 kg or more than 80 kg, or more than 25% above ideal body weight.
  • Present cardiac disease present.
  • Diseases or conditions known to affect bone metabolism.
  • Therapies with drugs that affect bone metabolism within 6 months.
  • Fluoride or Biophosphonates at any time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jerry L. Pettis Memorial Veterans Medical Center

Loma Linda, California, 92357, United States

Location

MeSH Terms

Conditions

Osteoporosis, PostmenopausalOsteoporosis

Interventions

Parathyroid Hormone

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
FED

Study Record Dates

First Submitted

July 3, 2001

First Posted

July 5, 2001

Study Start

November 1, 1998

Study Completion

October 1, 2003

Last Updated

January 21, 2009

Record last verified: 2004-12

Locations

US(1)