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OsteoporosisPhase 4ForsteoNCT01293292

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

A Phase 4 study testing Teriparatide in people with Osteoporosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 84 years, women only
Conditions the study is for
Osteoporosis
What is being tested?
Teriparatide
Type of treatment
Injection or infusion
How many people
19 participants
Where
1 siteUnited Kingdom
Study dates
Jan 2011to Aug 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 84 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 31Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, South Yorkshire, S5 7AU

Other trials in United Kingdom

About this study

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

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.

Conditions
Osteoporosis
Being tested
Teriparatide
Keywords
Osteoporosis, Forsteo, Teriparatide
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TeriparatideDrug

    Also called Forsteo

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 0 to 104 weeks

Secondary outcomes (3)

  1. 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.

    Measured: 0 to 104 weeks

  2. 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.

    Measured: 0 to 104 weeks

  3. 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.

    Measured: 0 to 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01293292
Sponsor's protocol ID
STH15466
Other IDs
2010-021009-19
Acronym
Forsteo
Status last verified
May 2026
First submitted
4 Feb 2011
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No

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.

    PubMed 29365099

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Teriparatide in people with Osteoporosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volumetric bone mineral density (BMD) of the lumbar spine (mg hydroxyapatite/cm3) (time frame: 0 to 104 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01293292, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

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