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

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ClinicalTrials.gov Identifier: NCT01293292
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE February 4, 2011
First Posted Date  ICMJE February 10, 2011
Last Update Posted Date May 8, 2017
Study Start Date  ICMJE January 2011
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2011)
Volumetric bone mineral density (BMD) of the lumbar spine (mg hydroxyapatite/cm3) [ Time Frame: 0 to 104 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2011)
  • Lumbar spine, total hip and whole body bone mineral density (g/cm2) [ Time Frame: 0 to 104 weeks ]
    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 [ Time Frame: 0 to 104 weeks ]
    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) [ Time Frame: 0 to 104 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action
Official Title  ICMJE Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action. A Two-year Open-label Single-arm Study of Teriparatide in Secondary Care
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis
Intervention  ICMJE Drug: Teriparatide
Teriparatide (Forsteo) 20 mcg subcutaneous injection once daily. Duration 104 weeks.
Other Name: Forsteo
Study Arms  ICMJE Not Provided
Publications * Gossiel F, Scott JR, Paggiosi MA, Naylor KE, McCloskey EV, Peel NFA, Walsh JS, Eastell R. Effect of Teriparatide Treatment on Circulating Periostin and Its Relationship to Regulators of Bone Formation and BMD in Postmenopausal Women With Osteoporosis. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1302-1309. doi: 10.1210/jc.2017-00283.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2016)
19
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2011)
20
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 84 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01293292
Other Study ID Numbers  ICMJE STH15466
2010-021009-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sheffield Teaching Hospitals NHS Foundation Trust
Study Sponsor  ICMJE Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Richard Eastell, MD, FRCP, FRCPath, FMedSci University of Sheffield
Principal Investigator: Jennifer Walsh, PhD MRCP Sheffield Teaching Hospitals NHS Foundation Trust
Principal Investigator: Eugene McCloskey, MD, FRCPI University of Sheffield
Principal Investigator: Nicola Peel, DM FRCP Sheffield Teaching Hospitals NHS Foundation Trust
Principal Investigator: Angela Rogers, BSc (Hons), PhD, MCSP University of Sheffield
Principal Investigator: Margaret Paggiosi, Bsc (Hons), PhD, MICR Sheffield Teaching Hospitals NHS Foundation Trust
Principal Investigator: Lang Yang, PhD CSci University of Sheffield
Principal Investigator: David Hughes, BMedSci MBChB PhD FRCPath Sheffield Teaching Hospitals NHS Foundation Trust
Principal Investigator: Mark Wilkinson, PhD, FRCS (Tr&Orth) University of Sheffield
PRS Account Sheffield Teaching Hospitals NHS Foundation Trust
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP