NCT01293292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

4.6 years

First QC Date

February 4, 2011

Last Update Submit

May 15, 2026

Conditions

Osteoporosis

Keywords

OsteoporosisForsteoTeriparatide

Outcome Measures

Primary Outcomes (1)

  • 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.

    0 to 104 weeks

Secondary Outcomes (3)

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

    0 to 104 weeks

  • Biochemical markers of bone turnover

    0 to 104 weeks

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

    0 to 104 weeks

Interventions

TeriparatideDRUG

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

Also known as: Forsteo

Eligibility Criteria

AgeUp to 84 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 29365099DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Richard Eastell, MD, FRCP, FRCPath, FMedSci

    University of Sheffield

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2011

First Posted

February 10, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

May 19, 2026

Record last verified: 2026-05

Locations

GB(1)