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Completed

NCT Number: NCT00259298

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

50 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

London, SE1 9RT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teriparatide

Drug

Subcutaneous, 20 microgram (mcg)/day, 18 months

Other names: LY333334, Forteo, Forsteo

Primary outcomes

  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

    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

  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

    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

    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

    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

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

The Use of Nuclear Scintigraphy to Evaluate the Anabolic Effects of Teriparatide on the Skeleton in Postmenopausal Women With Osteoporosis

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Nov 29, 2005
Registry last updated
Aug 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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