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Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption

NCT03710889 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-10-15

Study results available
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Summary

The objective of this study is to measure the early effects of abaloparatide on tissue-based bone formation using samples obtained by transiliac crest bone biopsy after quadruple fluorochrome labeling.

Conditions

  • Osteoporosis, Postmenopausal
  • Osteoporosis
  • Osteoporosis Vertebral
  • Osteoporosis Risk
  • Osteoporosis Fracture
  • Osteoporosis Localized to Spine
  • Osteoporosis, Age-Related
  • Osteoporosis Senile
  • Osteoporosis of Vertebrae

Interventions

DRUG

Abaloparatide

Abaloparatide is a novel, synthetic, 34 amino acid peptide designed to be a potent and selective activator of the PTH/PTH-related protein (PTHrP) type 1 receptor (PTHR1) signaling pathway with 41% homology to PTH\[1-34\] and 76% homology to human PTHrP\[1-34\].

Sponsors & Collaborators

  • Radius Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Radius Health, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-20
Primary Completion
2020-07-15
Completion
2020-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03710889 on ClinicalTrials.gov