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rhPTH Therapy for Low Turnover Bone Fragility

Primary Purpose

Osteopetrosis

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rhPTH
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteopetrosis focused on measuring low bone turnover; sclerosing bone disorders,, osteopetrosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: :patients with history of increased bone fragility by BMD criteria (T score > -1). In addition, the subjects will be enrolled only if they have clear evidence of low bone turnover as indicated by low normal levels of biochemical markers of bone turnover and finding of low bone turnover on bone biopsy. Each subject and his/her treating physician will have agreed that the rhPTH is the best treatment for the patient. Treatment with rhPTH will be considered only if the bone histomorphometry reveals a low turnover state and excludes other known forms of bone disease such as osteomalacia. Exclusion Criteria: Subjects who are pregnant or younger than 20 will be excluded. Subjects cannot have osteoporosis

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rhPTH

Arm Description

Subjects will be treated rhPTH for 12 months

Outcomes

Primary Outcome Measures

To describe the acute effects of rhPTH administration on calcium balance.
The effects on calcium balance will be examined at the beginning, after 3 months, and after 12 months of treatment with rhPTH. The rational for examining calcium balance at these three time points is that (at least in patients wit osteoporosis treated with PTH) the initial response is primarily an increase in bone formation; at 3 months there is also a proportionate increase in bone resorption; and at 12 months there is an established general increase in bone turnover.

Secondary Outcome Measures

To examine the effect of 12 months of therapy with rhPTH on bone density, bone turnover and bone micro-architecture.
Bone density will be measured at 0, 3, 6, and 12 months in the lumbar spine, proximal femur, and distal radius using Lunar Prodigy, and in the calcaneus using Lunar PIXI (both from GE Medical Systems, Madison, Wisconsin).

Full Information

First Posted
September 1, 2005
Last Updated
January 8, 2016
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00145886
Brief Title
rhPTH Therapy for Low Turnover Bone Fragility
Official Title
Effect of 12 Months Treatment With rhPTH on Calcium Balance, Bone Turnover, Bone Mineral Density, and Bone Micro-architecture in Patients With Fractures Associated With Low Bone Turnover and Sclerosing Bone Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
February 2003 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine how treatment with a new medication, recombinant human parathyroid hormone (rhPTH) affects calcium balance and bone strength.
Detailed Description
Subjects will have had a bone biopsy to definitively determine low bone turnover. Subjects and the treating doctor decide that treatment with rhPTH (recombinant human parathyroid hormone) is optimal before admission into the study. During the study, subjects will have several tests that will clarify how rhPTH is affecting calcium metabolism and bone properties. All of the studies will be performed in the University of Chicago General Clinical Research Center (GCRC). To examine the effects of PTH (parathyroid hormone) on calcium metabolism, subjects will be admitted to the GCRC for 3 days in the beginning of the study. Subjects will have a plastic needle inserted into a vein to enable the nurses to draw your blood repeatedly without having to stick you every time. Subjects will have 120 mL (about 8 tablespoons) of blood drawn during the 3 day period. Subjects will be allowed to choose the food from the regular hospital menu but the amount of calcium from the diet will be the same during each day that you spend in the GCRC. The first day will be used to observe calcium balance without medication while the subsequent 2 days will be used to determine how calcium balance changes in response to the medication rhPTH. Subjects will take the medication in the morning, before breakfast - this will be considered time 0. During all 3 days, blood will be taken at 0, 2, 4, 6, 8, 12, 16, and 20 hours for examination of serum calcium and at 0, 4 and 12 hours for measurement of PTH (that is produced by your body). On the first and 3rd day all the urine will be collected to measure how much calcium is lost in the urine. After Subjects have received the medication for 3 months they will again be admitted to the GCRC, this time for 2 days during which they will continue to take the medication with the same measurements as on the last 2 days of the first admission. The same admission will be repeated after 12 months of treatment. During each of these admissions, you will have 80 mL (about 5 ½ tablespoons) of blood drawn. In addition to these 3 inpatient stays in the CRC, subjects will also have several tests as an outpatient. The tests will be used to evaluate the effect of rhPTH on the bone. To this end, you will have 3 types of tests. To evaluate the bone turnover (activity of bone cells) subjects will have blood and urine collected for measurement of biochemical markers of bone turnover (chemicals in the blood and urine that reflect the activity of bone cells) measured before and at 1, 2, 3, 6, 9, and 12 months. Subjects will have 10 mL (about 2 teaspoons) of blood drawn at each of these visits. To evaluate changes in the bone density subjects will have bone density test of the lumbar spine, hip, heel and wrist measured every 3 months for 12 months. To evaluate changes in the architecture or structure of the bone subjects will have 2 tests. First, the heel images that are obtained during the bone density test (under #2) will be subjected to radiographic texture analysis. This is a method of computerized analysis of the pattern of bone radiographic images which is supposed to differentiate between strong and weak bone based on the difference in the radiographic texture. The second test will be a bone biopsy. A bone biopsy involves inserting a needle through the skin and directly into the bone to obtain a piece of the bone of 1 cm (less than ½ inch) in length and 0.3 cm (1/10 inch) in diameter. Before this biopsy needle is inserted a numbing medication is injected to prevent pain during the procedure. You will also receive a medication through the vein so that you will be almost asleep during the procedure (intravenous sedation). Most people only experience minor pain for a few days after the biopsy. Subjects will have had the first bone biopsy before enrolling into this study. A second bone biopsy will be performed after 12 months of treatment with rhPTH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopetrosis
Keywords
low bone turnover; sclerosing bone disorders,, osteopetrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rhPTH
Arm Type
Experimental
Arm Description
Subjects will be treated rhPTH for 12 months
Intervention Type
Drug
Intervention Name(s)
rhPTH
Other Intervention Name(s)
Recombinant Human Parathyroid Hormone
Intervention Description
Subjects will be treated with rhPTH for 12 months.
Primary Outcome Measure Information:
Title
To describe the acute effects of rhPTH administration on calcium balance.
Description
The effects on calcium balance will be examined at the beginning, after 3 months, and after 12 months of treatment with rhPTH. The rational for examining calcium balance at these three time points is that (at least in patients wit osteoporosis treated with PTH) the initial response is primarily an increase in bone formation; at 3 months there is also a proportionate increase in bone resorption; and at 12 months there is an established general increase in bone turnover.
Time Frame
The effects on calcium balance will be examined at the beginning, after 3 months, and after 12 months of treatment with rhPTH.
Secondary Outcome Measure Information:
Title
To examine the effect of 12 months of therapy with rhPTH on bone density, bone turnover and bone micro-architecture.
Description
Bone density will be measured at 0, 3, 6, and 12 months in the lumbar spine, proximal femur, and distal radius using Lunar Prodigy, and in the calcaneus using Lunar PIXI (both from GE Medical Systems, Madison, Wisconsin).
Time Frame
Bone density will be measured at 0, 3, 6, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: :patients with history of increased bone fragility by BMD criteria (T score > -1). In addition, the subjects will be enrolled only if they have clear evidence of low bone turnover as indicated by low normal levels of biochemical markers of bone turnover and finding of low bone turnover on bone biopsy. Each subject and his/her treating physician will have agreed that the rhPTH is the best treatment for the patient. Treatment with rhPTH will be considered only if the bone histomorphometry reveals a low turnover state and excludes other known forms of bone disease such as osteomalacia. Exclusion Criteria: Subjects who are pregnant or younger than 20 will be excluded. Subjects cannot have osteoporosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara Vokes, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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