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Calcium Supplementation in Postmenopausal Women

NCT00172172 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2021-05-25

No results posted yet for this study

Summary

This study is evaluating the effects of calcium supplementation on the efficacy and safety of recombinant parathyroid hormone (ALX1-11) in postmenopausal women with osteoporosis. The primary objective of this clinical study is to evaluate whether increases in bone mineral density (BMD) for subjects treated with ALX1-11 and receiving no calcium supplementation are less than increases in BMD observed for subjects treated with ALX1-11 and receiving calcium supplementation.

Conditions

Interventions

DRUG

PTH/Calcium

PTH(1-84) subcutaneous injection and calcium 700 mg oral

DRUG

PTH/placebo

PTH (1-84) injected subcutaneously and placebo provided orally

DRUG

placebo

Placebo injected subcutaneously and 700 mg calcium orally

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-10
Primary Completion
2005-03-11
Completion
2005-03-11

Countries

  • United States
  • Argentina
  • Mexico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00172172 on ClinicalTrials.gov