OsteoporosisPhase 4NCT00479037

Effect of Full Length Parathyroid Hormone, PTH(1-84) or Strontium Ranelate on Bone Markers in Postmenopausal Women With Primary Osteoporosis (FP-006-IM)

A Phase 4 study testing Full Length Parathyroid Hormone, PTH(1-84) and Strontium Ranelate in people with Osteoporosis, run by Nycomed at 1 site in Denmark.

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

The primary objective of this trial is to show that PTH(1-84) is superior to strontium ranelate in bone formation measured as changes in bone formation markers over a treatment period of 24 weeks in postmenopausal women with primary osteoporosis. Read more about this study

Who is it for?: Ages 50 years and older, women only
Conditions the study is for: Osteoporosis
What is being tested?: Full Length Parathyroid Hormone, PTH(1-84) and Strontium Ranelate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteDenmark
Study dates: Apr 2007to Jul 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Postmenopausal women at or above the age of 50, diagnosed with primary osteoporosis may be enrolled in the trial if the following inclusion/exclusion criteria apply.
All inclusion criteria must be answered "yes" for a subject to be enrolled in the trial.
Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject).
Is the subject female and at or above the age of 50?
Has the subject been postmenopausal for more than 5 years - in the judgement of the investigator?
Does the subject have primary osteoporosis and a T-score equal to or lower than -2.5 SD; T-scores must be assessed by DXA at the lumbar spine L1-L4, with a minimum of two assessable vertebrae, or at the total hip (right hip, if there is a right hip prosthesis, left hip can be used. If both hips are replaced the subject can be included with a lumbar scan only).

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Is the subject currently taking calcium and vitamin D3 or is she willing to start such supplemental treatment and continue throughout the trial period, unless she develops hypercalcaemia?
Has the subject been taking supplemental calcium (1,000 mg) and vitamin D3 (800 IU) daily for at least 14 days (after screening) before blood sampling for eligibility evaluation? [*]
Is the subject able to self-inject PTH(1-84), or get the injections by a helper?
[] Note that inclusion criteria no. 6 can not be evaluated at the time for screening, must be evaluated at randomisation, visit 2. See also exclusion criteria and note [].

Who cannot join

All exclusion criteria must be answered "no" for a subject to be enrolled in the trial.
Has the subject:
been treated with SERMS (selective oestrogen receptor modulators) or calcitonin within the last 1 month?
ever been treated with any bisphosphonate in intravenous form (i.v.)?
been treated with any bisphosphonates (alendronate, risedronate, or other bisphosphonates) for more than 3 years in total, or within the last 6 months?
been treated with fluoride for more than 3 months within the last 10 years?

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ever been treated with strontium ranelate?
ever been treated with teriparatide or PTH(1-84)?
received or is the subject currently receiving chronic glucocorticosteroid treatment?
Defined as more or equal to:
5.0 mg prednisolon or equivalent daily for 3 months during the last year or 2.5 mg prednisolon or equivalent daily for 6 months during the last year. Local and inhalation steroids are permitted.
been treated for cancer (other than basocellular skin cancer) within the last 5 years?
ever received radiation therapy to the skeleton?
ever had malignant disease affecting the skeleton? or does the subject:
currently receive antiepileptic medication?
take any other medication (other than calcium and vitamin D3) that is known to affect bone metabolism? - according to the investigator's opinion.
have any known clinically significant diseases affecting calcium metabolism?
have any known history of metabolic bone diseases other than primary osteoporosis including hyperparathyroidism, Paget's disease, osteogenesis imperfecta, or osteomalacia)?
have any known history of hypersensitivity to parathyroid hormone or strontium or any of the excipients in the products?
have a serum vitamin D3, (serum 25(OH)D) level <20 ng/ml after at least 14 days of calcium and vitamin D3 supplementation? [**]
have a serum PTH of > 65 pg/ml and also a total serum calcium value >2.49 mmol/l? [**]
have hypercalcaemia (total serum calcium value >2.55 mmol/l), measured after at least 14 days of calcium and vitamin D3 supplementation? [**]
have elevated serum alkaline phosphatase? Defined as > 3X ULN [**]
have impaired kidney function with creatinine clearance < 30 ml/min (indirect measurement by serum creatinine)? [**]
have severe impaired liver function ? [**]
have phenylketonuria? or is the subject:
at risk of having venous thromboembolism including pulmonary embolism? - according to the investigator's opinion.
scheduled for vertebroplasty?
currently participating in a clinical trial with an investigational medical product, or has done so within the last 90 days, or plan to do so within the next 32 weeks? Previous and current participation in non-interventional trials is allowed.
[] exclusion criteria no. 16 to 21 can not be evaluated before the result of the blood sampling (planned within the screening period and after at least 14 days of supplemental calcium/vitamin D3 intake) is available.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Nycomed
Roskilde, 4000

Other trials in Denmark

About this study

Official title: A 24-week, International, Multi Centre, Randomised, Open Label, Parallel Group, Phase IV Clinical Trial Investigating Changes in Bone Formation Markers in Postmenopausal Women With Primary Osteoporosis Treated With Either PTH(1-84) or Strontium Ranelate

Conditions: Osteoporosis
Being tested: Full Length Parathyroid Hormone, PTH(1-84), Strontium Ranelate
Keywords: postmenopausal women with primary osteoporosis
Medical subject headings: Osteoporosis

What participants receive

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

Full Length Parathyroid Hormone, PTH(1-84)Drug
Also called Preotact
Once daily subcutaneous injection in the abdomen by self administration
Strontium RanelateDrug
The daily dose of 2 g (one sachet) strontium ranelate was to be mixed in a glass of water and taken immediately after mixing at bedtime at least 2 hours before or after intake of calcium, any food or drinks, other than water

Study groups in NCT00479037
Study group	Role	What they receive
PTH(1-84)	Active comparator	Not described Receives: Drug: Full Length Parathyroid Hormone, PTH(1-84)
Strontium Ranelate	Active comparator	Not described Receives: Drug: Strontium Ranelate

What is being measured

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

Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial
P1NP is a bone formation marker that is derived from the amino-terminal propeptides of type I collagen and is considered a quantitative measure of newly formed type I collagen.
Bone marker measurements were done by blood analysis.
Measured: Baseline and 24 weeks of treatment
Percentage Change in the Bone Formation Marker Bone Specific Alkaline Phosphatase (BSAP) From Baseline to End of Trial
BSAP is a marker of bone formation that reflects the cellular activity of osteoblasts.
Bone marker measurements were done by blood analysis.
Measured: Baseline and 24 weeks of treatment

Secondary outcomes (1)

Percentage Change in the Bone Resorption Marker C-Telopeptide Cross-links (CTX) From Baseline to End of Trial
CTX is a marker of bone resorption, which is a degradation product of bone collagen.
Bone marker measurements were done by blood analysis.
Measured: Baseline and 24 weeks of treatment

Timeline

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

Apr 2007Jul 2009

First posted25 May 2007 (estimated)
Study startApr 2007
Primary completionFeb 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoporosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00479037
Sponsor's protocol ID: FP-006-IM
Other IDs: 2006-006065-16
Status last verified: May 2012
First submitted: 23 May 2007
Last updated: 8 May 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24-week, International, Multi Centre, Randomised, Open Label, Parallel Group, Phase IV Clinical Trial Investigating Changes in Bone Formation Markers in Postmenopausal Women With Primary Osteoporosis Treated With Either PTH(1-84) or Strontium Ranelate
ClinicalTrials.gov ID: NCT00479037
Acronym / sponsor ID: FP-006-IM
Conditions: Osteoporosis
Keywords: postmenopausal women with primary osteoporosis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: NycomedIndustry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Feb 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 25 May 2007 (estimated)
Results: Posted 28 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PTH(1-84)	Active comparator	Drug: Full Length Parathyroid Hormone, PTH(1-84)
Strontium Ranelate	Active comparator	Drug: Strontium Ranelate

Who may qualify

Ages: 50 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Postmenopausal women at or above the age of 50, diagnosed with primary osteoporosis may be enrolled in the trial if the following inclusion/exclusion criteria apply.
All inclusion criteria must be answered "yes" for a subject to be enrolled in the trial.
Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject).
Is the subject female and at or above the age of 50?
Has the subject been postmenopausal for more than 5 years - in the judgement of the investigator?

Key exclusion criteria (30 listed)

All exclusion criteria must be answered "no" for a subject to be enrolled in the trial.
been treated with SERMS (selective oestrogen receptor modulators) or calcitonin within the last 1 month?
ever been treated with any bisphosphonate in intravenous form (i.v.)?
been treated with any bisphosphonates (alendronate, risedronate, or other bisphosphonates) for more than 3 years in total, or within the last 6 months?
been treated with fluoride for more than 3 months within the last 10 years?

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Full Length Parathyroid Hormone, PTH(1-84)Also: PreotactOnce daily subcutaneous injection in the abdomen by self administration	Drug	PTH(1-84)
Strontium RanelateThe daily dose of 2 g (one sachet) strontium ranelate was to be mixed in a glass of water and taken immediately after mixing at bedtime at least 2 hours before or after intake of calcium, any food or drinks, other than water	Drug	Strontium Ranelate

Primary outcome

Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial
Time frame: Baseline and 24 weeks of treatment
P1NP is a bone formation marker that is derived from the amino-terminal propeptides of type I collagen and is considered a quantitative measure of newly formed type I collagen. Bone marker measurements were done by blood analysis.
Percentage Change in the Bone Formation Marker Bone Specific Alkaline Phosphatase (BSAP) From Baseline to End of Trial
Time frame: Baseline and 24 weeks of treatment
BSAP is a marker of bone formation that reflects the cellular activity of osteoblasts. Bone marker measurements were done by blood analysis.

1 secondary outcome

Percentage Change in the Bone Resorption Marker C-Telopeptide Cross-links (CTX) From Baseline to End of Trial
Time frame: Baseline and 24 weeks of treatment

Results and safety

Results posted to the registry on 28 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PTH(1-84)	41	38
Strontium Ranelate	40	34

Primary outcome: Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial

Time frame: Baseline and 24 weeks of treatment. Mean (Standard Deviation). Unit: percent change

Measure	PTH(1-84) n = 41	Strontium Ranelate n = 40
Value	446.1 (355.3)	-6.2 (36.9)

PTH(1-84) vs Strontium Ranelate: Mean Difference (Net): 360.3 (95% CI 256.5 to 494.3), p <0.0001, ANCOVA

Population analysed: ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.

Primary outcome: Percentage Change in the Bone Formation Marker Bone Specific Alkaline Phosphatase (BSAP) From Baseline to End of Trial

Time frame: Baseline and 24 weeks of treatment. Mean (Standard Deviation). Unit: percent change

Measure	PTH(1-84) n = 41	Strontium Ranelate n = 40
Value	129.6 (100.3)	4.9 (22.9)

PTH(1-84) vs Strontium Ranelate: Mean Difference (Net): 92.9 (95% CI 63.8 to 127.1), p <0.0001, ANCOVA

Population analysed: ITT analysis. Number of participants analyzed = number of participants with data available.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PTH(1-84)	2 of 40 (5%)	29 of 40 (72.5%)	Not reported
Strontium Ranelate	2 of 40 (5%)	19 of 40 (47.5%)	Not reported

Limitations and caveats (from the sponsor): A limitation of the trial was the open label design, however this is not considered to affect the primary or secondary outcome of the trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoporosis

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Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nycomed Clinical Trial Operations study chair

Headquarters

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Full Length Parathyroid Hormone, PTH(1-84) and Strontium Ranelate in people with Osteoporosis, run by Nycomed at 1 site in Denmark.

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 10 inclusion and 30 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 8 May 2012. 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 Denmark. 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?

Yes. Results are posted in the registry (first posted 28 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial (time frame: Baseline and 24 weeks of treatment). The study lists 2 primary outcomes in all. 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 NCT00479037.

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 8 May 2012.