Skip to content

Trial · Interventional

CompletedPhase 4Results postedRegistry data

Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis

NCTNCT00259298 (opens ClinicalTrials.gov in a new tab)Other id9917Other idB3D-US-GHCV
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
12 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United Kingdom

Start
Nov 2005
Primary completion
Jul 2009
Completion
Jul 2009
First posted
29 Nov 2005 (estimated)
Last update posted
11 Aug 2010 (estimated)
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200520062007200820092010
  1. Ph 4

    Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis

    NCT00259298

    Nov 2005 to Jul 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to evaluate the effects of teriparatide on skeleton images in postmenopausal women with osteoporosis. Teriparatide is a bone formation agent that stimulates the production of new bone in the skeleton. This process of bone formation can be studied using a technique commonly referred to as a bone scan or nuclear scintigraphy. This trial will test whether bone scans will identify areas of the skeleton that are forming new bone during teriparatide therapy. It also will study what these areas look like after therapy is stopped.

Interventions

  • teriparatideDrug

Arms1

  • Experimental

    Teriparatide

    Participants receive teriparatide 20 microgram once daily by subcutaneous injection for 18 months followed by 6 months off therapy

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months

    Time frame · baseline, 18 months

    Registry description

    Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone).

Secondary outcomes(4)

  1. Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities

    Time frame · Baseline, 3 months, 18 months, 24 months

    Registry description

    Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone) and to derive regional values for the skull, mandible, spine, pelvis, and upper and lower extremities.

  2. Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities

    Time frame · Baseline, 3 months, 18 months, 24 months

    Registry description

    Skeletal uptake describes the percent uptake of radionuclide tracer by the skeleton when compared to baseline or other post-baseline measures. Skeletal uptake is defined as percentage of uptake of 99mTc-MDP 4 hours after injection. This value differs from skeletal plasma clearance measurements because it only quantifies the amount of 99mTc-MDP taken up by bone without consideration of concentration of tracer in the plasma.

  3. Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton

    Time frame · Baseline, 3 months, 18 months, 24 months

    Registry description

    Changes in focal uptake (localized, defined areas of uptake) were visually scored and compared to baseline or other post-baseline assessments. Changes were rated on a scale from 0-4: 0=no clinically significant focal areas of skeletal uptake; 1=focal areas affecting \<1% of skeleton; 2=focal areas affecting \>=5% of skeleton; 3=focal areas affecting \>=20% of skeleton; 4=focal areas affecting \>=50% of skeleton.

  4. Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton

    Time frame · baseline, 3 months, 18 months, 24 months

    Registry description

    Changes in diffuse uptake were determined by comparing diffuse uptake to baseline or other post-baseline observations. Diffuse uptake indicates response to therapy (during active treatment, increased diffuse uptake was expected; after the 6-month withdrawal period, decreased diffuse uptake was expected). Qualitative visual scoring of changes in the bone scan images were performed jointly by 3 reviewers who classified changes in the whole skeleton into 4 groups as follows: possible decreased response, no response, possible response, and definite response.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· baseline, 18 months

Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months

GroupValue (percentage of change of plasma clearance)
Teriparatide33.75
Secondary and other outcome results(4)
Secondary outcomeMedian· Baseline, 3 months, 18 months, 24 months

Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities

GroupValue (percentage of change of plasma clearance)
Teriparatide25.02
Secondary outcomeMedian· Baseline, 3 months, 18 months, 24 months

Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities

GroupValue (percentage of change of skeletal uptake)
Teriparatide15.63
Secondary outcomeMean· Baseline, 3 months, 18 months, 24 months

Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton

GroupValue (units on a scale)Spread
Teriparatide0.10.32
Secondary outcomeNumber· baseline, 3 months, 18 months, 24 months

Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton

GroupValue (participants)
Teriparatide2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
TeriparatideParticipants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy–1 / 1212 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2010

9 results

Assessment of regional changes in skeletal metabolism following 3 and 18 months of teriparatide treatment.

Moore et al. 2010Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 30

PMID 19929434DOI 10.1359/jbmr.091108PUB-19929434

Full text at the publisher9 results
Publisher pageSee results (9)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 50 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Ambulatory with osteoporosis * Hip or spine bone mineral density (BMD) measurement more than 2.5 standard deviations below the average bone mass of young healthy women or more than 2.0 standard deviations in women who have a history of a vertebral or nonvertebral fragility fracture. Exclusion Criteria: * Diseases of bone other than osteoporosis * Treatment with estrogens in the 3 months prior to enrollment or for more than 2 months in the past year * Treatment with oral bisphosphonates in the 3 months prior to enrollment or for more than 2 months in the past year; treatment with intravenous bisphosphonates in the 12 months prior to enrollment * Increased risk for the development of osteosarcoma

PepBank is a research reference. Talk to a doctor before you use any peptide.