Completed

Evaluation of Factors That Affect Skeletal Responses to PTH

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What is being tested

synthetic hPTH 1-34

Drug
Who is being recruted

Bone Diseases+3

+ Bone Diseases, Metabolic

+ Metabolic Diseases

From 46 to 85 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2004

Actual date on which the first participant was enrolled.

In women with postmenopausal osteoporosis, PTH increases bone mineral density more than anti-resorptive agents, and its use markedly reduces the incidence of new spine and non-spine fractures. Still, PTH is not a cure for osteoporosis in many patients because PTH-stimulated bone formation declines as PTH therapy continues. Biochemical analyses suggest that bone formation and resorption peak after 6 to 9 months of daily PTH therapy and then decline progressively. The study will last 18 months. Blood, urine, and bone density tests will occur at screening. At the start of the study, participants will be randomly assigned to one of two PTH dose regimens. Patients will go to Massachusetts General Hospital at Months 0, 3, 6, 9, 12, 15, and 18 for blood and urine collection. In addition, bone density tests by DXA will be performed at Months 0, 6, 12, and 18, and by quantitative CT scans at Months 0 and 18. Approximately 6 weeks after any change in PTH dose, each participant's blood calcium will be checked 4 to 6 hours after that day's PTH injection, and her 24-hour urine calcium excretion will also be checked. Participants may enroll in optional substudies that will test whether reduced skeletal responses to long-term treatment with PTH are accompanied by changes in its absorption and/or destruction and whether reduced skeletal responses to long-term treatment with PTH are accompanied by parallel reductions in kidney responses to PTH.

Official TitleEvaluation of Factors That Affect Skeletal Responses to PTH 
NCT00086619
Principal SponsorMassachusetts General Hospital
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 46 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesBone Diseases, MetabolicMetabolic DiseasesMusculoskeletal DiseasesOsteoporosisOsteoporosis, Postmenopausal

Criteria

Inclusion Criteria: * Three or more years after menopause * Bone mineral density T-score \< or = -2.0 by dual-energy x-ray absorptiometry (DXA) of vertebrae or femoral neck, or by quantitative computerized tomography (QCT) of vertebral body trabeculae Exclusion Criteria: * Cannot walk without assistance * Significant heart, kidney, liver, or malignant disease * Current alcohol abuse * Major psychiatric disorders * Other current or past disorders known to affect bone * Use of medications known to affect bone for \> 7 days in the past 12 months * Use of bisphosphonates or fluoride * Abnormal blood calcium, PTH, 25-hydroxy vitamin D, creatinine, liver function tests, or complete blood count * Elevated calcium levels in 24-hour urine collection

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive synthetic human parathyroid hormone fragment 1-34 (hPTH 1-34) once-daily in a dose that ascends at 6 month intervals (20-30-40 mcg/day).

Group II

Experimental
Participants will receive synthetic human parathyroid hormone fragment 1-34 (hPTH 1-34) once-daily in a constant dose of 30 mcg/day.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Massachusetts General Hospital

Boston, United StatesSee the location
CompletedOne Study Center