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Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action (Forsteo)

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Teriparatide

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, Forsteo, Teriparatide

Eligibility Criteria

undefined - 84 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria

Subjects must:

Have a bone mineral density T-score (at the lumbar spine or total hip) of less than or equal to -2.5
Be female
Be at least 5 years post menopausal (more than 5 years since their last menstrual period) but <85 years old.
Be ambulatory
Be able and willing to participate in the study and provide written informed consent
Have a serum 25(OH)2 vitamin D3 >50 nmol/L (after vitamin D3 loading)

Exclusion Criteria

Patients will not be admitted to the study if they exhibit any of the following:

Evidence of a clinically significant organic disease which could prevent the patient from completing the study
A body mass index less than 18 or greater than 35
Abuse of alcohol or use illicit drugs (information obtained from medical history) or who consumed more than 4 servings of any alcoholic beverage one day prior to the visit (i.e., subjects who might be binge drinkers)
Any history of cancer within the past 5 years excluding skin cancer non melanomas
Any history of ongoing conditions or diseases known to cause abnormalities of calcium metabolism or skeletal health including Paget's disease of bone
Chronic renal disease (as defined by an estimated glomerular filtration rate of ≤ 30mL/min)
Acute or chronic hepatic disease
Malabsorption syndromes
Hyperthyroidism as manifested by TSH outside the lower limit of the normal range
Hyperparathyroidism
Hypocalcemia or hypercalcemia
Osteomalacia
Cushing's syndrome
Current use of glucocorticoid therapy
A corrected serum calcium less than 2.2 mmol/L and a PTH above 100 ng/L (that persists after testing and treatment for vitamin D deficiency)
A history of any known condition that would interfere with the assessment of DXA at either lumbar spine or femoral neck
Markedly abnormal clinical laboratory parameters that are assessed as clinically significant by the investigator
Any previous use of bisphosphonate
Use any of the following medications within 12 months of starting study drug
Any fluoride with the exception of use for oral hygiene
Strontium Ranelate
Other bone agents (e.g. SERM, isoflavones, HRT)
Participation in another clinical trial involving active therapy 3 months prior to enrolment
Less than 5 years since menopause
Bilateral fractures in the measurement regions (hip, tibia and forearm)
Recent fracture within the last 12 months
Prior radiation therapy which may involve the skeleton
Hypersensitivity to teriparatide or any of its excipients
Unexplained elevations of alkaline phosphatase
Any known contraindication to the use of teriparatide

Sites / Locations

Sheffield Teaching Hospitals NHS Foundation Trust

Outcomes

Primary Outcome Measures

Volumetric bone mineral density (BMD) of the lumbar spine (mg hydroxyapatite/cm3)

Change in volumetric BMD of the lumbar spine (vertebrae L1-3) (mg hydroxyapatite/cm3) measured by quantitative computed tomography (QCT) from 0 to 104 weeks treatment.

Secondary Outcome Measures

Lumbar spine, total hip and whole body bone mineral density (g/cm2)

Changes in lumbar spine, total hip and whole body bone mineral density (g/cm2) measured by dual x-ray absorptiometry (DXA) from 0 to 104 weeks.

Biochemical markers of bone turnover

Changes in biochemcial markers of bone turnover (OC, PINP, bone ALP, urinary NTX, serum CTX, sclerostin, DKK-1) from 0 to 104 weeks.

Distal tibia and radius volumetric body bone mineral density (BMD) (mg hydroxyapatite/cm3)

Changes in distal tibia and radius volumetric bone mineral density (mg hydroxyapatite/cm3) measured by High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) from 0 to 104 weeks.

Full Information

NCT ID

NCT01293292

First Posted

February 4, 2011

Last Updated

May 4, 2017

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT01293292

Brief Title

Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action

Acronym

Forsteo

Official Title

Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action. A Two-year Open-label Single-arm Study of Teriparatide in Secondary Care

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Previously the approach to treatment of osteoporosis has been to use medications which prevent excessive resorption of bone. More recently medications that build up new bone, i.e. anabolic treatments, have been, and are being, developed. The investigators would like to develop a strategy for evaluating the effectiveness of anabolic therapies by studying a currently available therapy (teriparatide). This strategy could then be used to assess new anabolic treatments as they are developed for use in humans. The aims of this study are 1) to fully describe the changes in bone turnover in response to teriparatide by biochemical marker type and by time; 2) to fully describe the changes in bone mineral density (BMD) in response to teriparatide by site, bone compartment and time. If this study is able to identify an early response to treatment, then this will help speed up drug development in this area, by allowing the identification of promising new anabolic drugs and enabling us to understand their mechanism of action. This will benefit the investigators patients as the investigators will have a better understanding of how these drugs work.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

Osteoporosis, Forsteo, Teriparatide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Teriparatide

Other Intervention Name(s)

Forsteo

Intervention Description

Teriparatide (Forsteo) 20 mcg subcutaneous injection once daily. Duration 104 weeks.

Primary Outcome Measure Information:

Title

Volumetric bone mineral density (BMD) of the lumbar spine (mg hydroxyapatite/cm3)

Description

Change in volumetric BMD of the lumbar spine (vertebrae L1-3) (mg hydroxyapatite/cm3) measured by quantitative computed tomography (QCT) from 0 to 104 weeks treatment.

Time Frame

0 to 104 weeks

Secondary Outcome Measure Information:

Title

Lumbar spine, total hip and whole body bone mineral density (g/cm2)

Description

Changes in lumbar spine, total hip and whole body bone mineral density (g/cm2) measured by dual x-ray absorptiometry (DXA) from 0 to 104 weeks.

Time Frame

0 to 104 weeks

Title

Biochemical markers of bone turnover

Description

Changes in biochemcial markers of bone turnover (OC, PINP, bone ALP, urinary NTX, serum CTX, sclerostin, DKK-1) from 0 to 104 weeks.

Time Frame

0 to 104 weeks

Title

Distal tibia and radius volumetric body bone mineral density (BMD) (mg hydroxyapatite/cm3)

Description

Changes in distal tibia and radius volumetric bone mineral density (mg hydroxyapatite/cm3) measured by High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) from 0 to 104 weeks.

Time Frame

0 to 104 weeks

10. Eligibility

Sex

Female

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Subjects must: Have a bone mineral density T-score (at the lumbar spine or total hip) of less than or equal to -2.5 Be female Be at least 5 years post menopausal (more than 5 years since their last menstrual period) but <85 years old. Be ambulatory Be able and willing to participate in the study and provide written informed consent Have a serum 25(OH)2 vitamin D3 >50 nmol/L (after vitamin D3 loading) Exclusion Criteria Patients will not be admitted to the study if they exhibit any of the following: Evidence of a clinically significant organic disease which could prevent the patient from completing the study A body mass index less than 18 or greater than 35 Abuse of alcohol or use illicit drugs (information obtained from medical history) or who consumed more than 4 servings of any alcoholic beverage one day prior to the visit (i.e., subjects who might be binge drinkers) Any history of cancer within the past 5 years excluding skin cancer non melanomas Any history of ongoing conditions or diseases known to cause abnormalities of calcium metabolism or skeletal health including Paget's disease of bone Chronic renal disease (as defined by an estimated glomerular filtration rate of ≤ 30mL/min) Acute or chronic hepatic disease Malabsorption syndromes Hyperthyroidism as manifested by TSH outside the lower limit of the normal range Hyperparathyroidism Hypocalcemia or hypercalcemia Osteomalacia Cushing's syndrome Current use of glucocorticoid therapy A corrected serum calcium less than 2.2 mmol/L and a PTH above 100 ng/L (that persists after testing and treatment for vitamin D deficiency) A history of any known condition that would interfere with the assessment of DXA at either lumbar spine or femoral neck Markedly abnormal clinical laboratory parameters that are assessed as clinically significant by the investigator Any previous use of bisphosphonate Use any of the following medications within 12 months of starting study drug Any fluoride with the exception of use for oral hygiene Strontium Ranelate Other bone agents (e.g. SERM, isoflavones, HRT) Participation in another clinical trial involving active therapy 3 months prior to enrolment Less than 5 years since menopause Bilateral fractures in the measurement regions (hip, tibia and forearm) Recent fracture within the last 12 months Prior radiation therapy which may involve the skeleton Hypersensitivity to teriparatide or any of its excipients Unexplained elevations of alkaline phosphatase Any known contraindication to the use of teriparatide

Overall Study Officials: