Completed

Clinical Trial of Parathyroid Hormone (PTH) and Alendronate in Combination in the Treatment of Osteoporosis

What is being tested

PTH

+ Alendronate

+ PTH

Drug

Who is being recruted

Bone Diseases+3

+ Bone Diseases, Metabolic

+ Metabolic Diseases

From 55 to 85 Years

+29 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: October 1999

See protocol details

Summary

Principal SponsorDennis Black

Last updated: February 5, 2013

Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1999

Actual date on which the first participant was enrolled.

The PaTH study is a 2-year, multicenter, double-blind, placebo-controlled trial to test the efficacy of combining hPTH (1-84) and alendronate for treating osteoporosis in postmenopausal women. 238 women were randomized between 55 and 85 years of age to receive either: (1) PTH for 1 year followed by alendronate for 1 year; (2) PTH and alendronate for 1 year followed by alendronate for 1 year; (3) alendronate for 2 years; or (4) PTH for 1 year followed by placebo for 1 year. The primary endpoints are changes in bone mineral density at several sites and changes in biochemical markers. In addition, we will assess specific biochemical markers of bone turnover (e.g., osteocalcin, deoxypridinoline, N-telopeptide, bone-specific alkaline phosphatase and bone sialoprotein) to determine if they can predict the skeletal response to combination therapy. We will also determine whether PTH positively affects ultrasound measurements in the calcaneus.

NCT00005005

Principal SponsorDennis Black

Last updated: February 5, 2013

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

238 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 55 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

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

Conditions

Pathology

Bone DiseasesBone Diseases, MetabolicMetabolic DiseasesMusculoskeletal DiseasesNutritional and Metabolic DiseasesOsteoporosis

Criteria

4 inclusion criteria required to participate

Aged between 55 and 85 years

Have a bone mineral density scan (DXA) that can be evaluated at the spine AND at the hip with a T-score equal to or below -2.5 at the spine or the femoral neck or total hip OR T-score equal to or below -2.0 at the spine or the femoral neck or total hip and have at least one of the following risk factors for fracture: (a) age > 65 years; (b) history of postmenopausal fracture (nonvertebral or vertebral); or (c) maternal history of hip fracture

Postmenopausal (have not had any menses in the last 5 years)

Willing and able to self-administer daily injections

25 exclusion criteria prevent from participating

Any history of hypercalciuria or currently have urine calcium/creatinine > 300 mg

Any history of kidney stones

Any major life-threatening illnesses

Currently taking > 1000 IU/day vitamin D or vitamin D analogues or metabolites

Show More Criteria

Study Plan

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

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive PTH for 1 year followed by alendronate for 1 year.

Group II

Experimental

Participants will receive PTH and alendronate for 1 year followed by alendronate for 1 year.

Group III

Experimental

Participants will receive alendronate for 2 years.

Group IV

Active Comparator

Participants will receive PTH for 1 year followed by placebo for 1 year.

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 4 locations

Maine Center for Osteoporosis

Bangor, United StatesOpen Maine Center for Osteoporosis in Google Maps

University of Minnesota

Minneapolis, United States

Columbia University

New York, United States

University of Pittsburgh Medical Center

Pittsburgh, United States

Completed4 Study Centers