Skip to content

Trial · Interventional

CompletedPhase 4Registry data

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

Short name Forsteo

NCTNCT01293292 (opens ClinicalTrials.gov in a new tab)Other idSTH15466Other id2010-021009-19

Overview

Status
Completed
Phase
Phase 4
Enrollment
19 participants (actual)
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United Kingdom

Start
Jan 2011
Primary completion
Aug 2015
Completion
Aug 2015
First posted
10 Feb 2011 (estimated)
Last update posted
19 May 2026
Conditions
Osteoporosis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013201420152016
  1. Ph 4

    Forsteo

    NCT01293292

    Jan 2011 to Aug 2015

Registry summary

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

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.

Interventions

  • TeriparatideDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 0 to 104 weeks

    Registry 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.

Secondary outcomes(3)
  1. Lumbar spine, total hip and whole body bone mineral density (g/cm2)

    Time frame · 0 to 104 weeks

    Registry 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.

  2. Biochemical markers of bone turnover

    Time frame · 0 to 104 weeks

    Registry description

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

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

    Time frame · 0 to 104 weeks

    Registry 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.

Posted results

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

No results are posted for this trial.

Completed trials do not always post results.

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

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2018

Effect of Teriparatide Treatment on Circulating Periostin and Its Relationship to Regulators of Bone Formation and BMD in Postmenopausal Women With Osteoporosis.

Gossiel et al. 2018The Journal of clinical endocrinology and metabolismcited by 20

PMID 29365099PMC6457025DOI 10.1210/jc.2017-00283PUB-29365099

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
Female
Age
up to 84 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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