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OsteoporosisPhase 3TRESNCT00172120

Open Label Extension

A Phase 3 study testing ALX1-11 in people with Osteoporosis, run by Shire at 12 sites in 2 countries.

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

TRES will evaluate the effects of continued ALX1-11 treatment on the safety and efficacy variables assessed in the OLE study for a maximum treatment duration of 36 months in OLES and TRES combined. Read more about this study

Who is it for?
Ages 45 years and older, women only
Conditions the study is for
Osteoporosis
What is being tested?
ALX1-11
How many people
91 participants
Where
12 sitesin 2 countries
Study dates
10 Jan 2005to 27 Oct 2006
Phase
Phase 3
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 45 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Received placebo in TOP
  • Completed 18 months of daily treatment with ALX1-11 in OLES
  • Received their last dose of ALX1-11 in OLES within 3 months (90 days) of dosing in this study
  • Have the ability to continue to self-administer, or have a designee administer, a daily injection
  • Have the ability to understand, and willingness to sign, an informed consent form (ICF)

Who cannot join

  • Subjects are excluded who have developed any of the exclusion criteria for OLES, or modifications as listed below.
  • Concurrent Diseases Subjects are excluded if they have developed any of the diseases or illnesses listed since enrollment in OLES.
  • Immune.Significant* immunological disorders; including AIDSAllergies to ALX1-11 or its constituents
  • Endocrine.Significant* endocrine disorders, including hyper or hypoparathyroidism, Cushing's disease, hyperthyroidism
  • Gastrointestinal (GI).Significant* GI disorders
  • Kidney and Collecting.Significant* renal disorders or impaired renal function, nephrolithiasis or urolithiasis, verified kidney calcification, etc.
Show all 56Show fewer
  • Liver, biliary tract, pancreatic.Significant* hepatic or pancreatic disorders, active hepatitis, or pancreatitis
  • Musculoskeletal.Metabolic bone disease, eg., Paget's disease, osteogenesis imperfecta, or osteomalacia -Chronic, active joint disease and/or joint infection
  • Neoplasia.Cancer, with the exception of squamous or basal cell carcinoma**
  • Nervous.Significant* neurological or psychiatric disease
  • Vascular, respiratory, and cardiac.Significant* unstable cardiac or pulmonary disease
  • ()Significance will be determined by the investigator on the basis of history, physical exam, and/or laboratory screens. Significant disorders necessitate ongoing changes in therapeutic medication or frequent monitoring.
  • ()Subjects who have had either squamous or basal cell carcinoma of the skin can enroll if: 1. The lesion(s) was fully resected with clear margins described in a written report by a pathologist, AND 2. The subject has had no recurrence of lesions for at least 1 year from the time of the original resection
  • Prohibited Concomitant Medications
  • PTH analogs*
  • Fluoride
  • Strontium
  • Calcitonin
  • Vitamin D metabolites or analogs(eg., calcitriol)
  • Immunomodulatory agents with antiproliferative activity
  • Cytostatics**
  • Thyroxine. Prohibited if dose > 0.2 mg/day (see Table 4-4 for allowed conditions)
  • Bisphosphonate
  • Anabolic steroids or androgens
  • ()PTH (parathyroid hormone) analogs include PTH(1-34), PTHrP, and other analogs
  • ()eg, azathioprine, recombinant human tumor necrosis fusion (Fc) protein, monoclonal antibody against tumor necrosis factor (e.g., infliximab [Remicade™])
  • Medications Requiring a Washout Period - Subjects who completed OLES and then began taking medications listed in the following table may enroll in this study after a washout period of 30 days.
  • Hormone-replacement therapy*
  • Methotrexate
  • SERMs**
  • Any investigational drug
  • Other medications known to affect the metabolism of bone
  • 30 days with PMO approval
  • ()Includes estrogen- and estrogen/progesterone-replacement therapy given by oral, transdermal, or intramuscular administration b SERMs (selective estrogen receptor modulator) include tamoxifen and raloxifene (Evista®) PMO = project medical officer
  • ()SERMs (selective estrogen receptor modulator) include tamoxifen and raloxifene (Evista®) PMO = project medical officer
  • Medications Allowed if Specific Conditions Are Met-Medications that are allowed under specific conditions are listed:
  • Thyroid hormone. At a stable dose <= 0.2 mg/day
  • Thiazide. At a stable dose
  • Vaginal application of estrogen-containing creams. Conjugated estrogen or estradiol at a dose of <=0.5 g administered twice each week (total of 1.0 g weekly). Estrace® (Ogen)at a dose <=1.0 g twice each week (total of 2.0 g weekly)
  • Systemic corticosteroids. Acute bolus of steroids (oral or injectable) for a self-limited illness allowed under the following conditions: 1. Exposure to steroids limited to £30 consecutive days 2. Maximal dose (prednisone-equivalent) does not exceed 225 mg (5 mg/day for 30 days) 3. Illness was acute in nature and not expected to recur during the remaining treatment period of the study
  • Inhaled corticosteroids. At a dose <1200 mg/day beclomethasone equivalent
  • Intra-articular injections. A single intra-articular injection allowed every 6 months if the dose of corticosteroid injected is less than an equivalent dose of prednisone 40 mg suspension
  • Phenytoin. No phenytoin exposure allowed within 5 years of Month 0 of TOP. Allowed if last phenytoin exposure was >15 years prior to screening for TOP or was between 5-15 years before screening for TOP and for <2 months duration
  • Provera® (medroxyprogesterone). Allowed if used according to the label
  • Laboratory Values and Physical Examination Findings - For excluded laboratory values, the levels shown in the following table are the upper limits for exclusions based on specific test results, with the exception of calculated creatinine clearance and serum 25(OH) vitamin D, for which the limits are lower. All exclusionary laboratory results should be confirmed by a repeat test. Subjects may be excluded for any other clinically abnormal value, as determined by the investigator.
  • Fasting serum total calcium (Ca). Subject excluded if value* >10.2 mg/dL,*
  • 24-hour urinary Ca. Subject excluded if value* >360 mg/day**
  • Serum total alkaline phosphatase. Subject excluded if value* 3X upper limit of normal for laboratory
  • Serum PTH***. Subject excluded if value* >50 pg/mL
  • Calculated creatinine clearance*** Subject excluded if value* <50 mL/minute
  • Serum 25(OH) vitamin D***. Subject excluded if value* <20 ng/mL
  • ()Exclude subject only if repeat assessment confirms the result.
  • ()Not to be used as a reason for premature discontinuation during the study. Subjects with elevated values after enrollment are to be managed by the appropriate algorithm (Appendices 2 and 3).
  • ()Not an exclusion criterion in OLES
  • Substance Abuse-Subjects are excluded for a history of alcohol and/or drug abuse as determined by the investigator.
  • Compliance-Subjects may be excluded for suspected or confirmed poor compliance in completing clinical trial evaluations and/or questionnaires.

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

United States9 sites

  • 'Osteoporosis Medical Center

    Beverly Hills, California, 90211

  • 'Odyssey Research Services

    Bismarck, North Dakota, 58501

  • 'Fletcher Allan Health Center, UHC Campus 1

    Burlington, Vermont, 05401

  • 'The University of Chicago

    Chicago, Illinois, 60637

  • 'Michigan Bone & Mineral Clinic

    Detroit, Michigan, 48236

  • Michael J. Lillestol

    Fargo, North Dakota, 58103

  • 'Odyssey Research Services

    Minot, North Dakota, 58701

  • 'Rapid City Medical Center

    Rapid City, South Dakota, 57701

  • 'Brown Clinic

    Watertown, South Dakota, 57201

Other trials in United States

Argentina3 sites

  • 'IDIM

    Buenos Aires, BUE, C1012AAR

  • 'Centro Médico T.I.E.M.P.O

    Buenos Aires, BUE, C1117ABH

  • 'Centro de Osteopatias Medicas

    Capital Federal, CBA, C1114AAI

Other trials in Argentina

About this study

Official title: An 18-month, Open-label Extension Study of Once-daily ALX1-11 for the Treatment of Postmenopausal Women With Osteoporosis (TRES)

TRES will evaluate the effects of continued ALX1-11 treatment on the safety and efficacy variables assessed in the OLE study for a maximum treatment duration of 36 months in OLES and TRES combined.

Read the detailed description

The primary goal of osteoporosis therapy is to prevent fracture, and anabolic agents can accomplish this by strengthening bone structure, which is accompanied by changes in BMD. Effects of ALX1-11 on BMD have been previously documented in a dose-finding Phase II clinical trial in osteoporotic postmenopausal women taking calcium and vitamin D supplements, who were otherwise naive to osteoporosis therapies. The anabolic effects of ALX1-11 on lumbar vertebrae were statistically significant compared to placebo after 12 months of treatment. In addition, animal studies showed that the new bone formed by treatment with ALX1 11 is of good quality both histologically and biomechanically (Mosekilde et al., 1991; Kimmel et al., 1993).

Protocol ALX1-11-93001 (TOP) assessed the effect of 18 months of ALX1-11 treatment on fracture incidence as a primary efficacy variable, and Protocol CL1-11-002 (OLES) assessed the effect on BMD for up to 24 months of treatment. Subjects who will be enrolled in the current study (TRES) will be those who received placebo in TOP and ALX1-11 in OLES. TRES will evaluate the effects of continued ALX1-11 treatment on the safety and efficacy variables assessed in the OLE study for a maximum treatment duration of 36 months in the OLES and TRES combined.

Conditions
Osteoporosis
Being tested
ALX1-11
Keywords
Post-menopausal, Osteoporosis, Parathyroid Hormone, PTH, ALX1-11
Medical subject headings
Osteoporosis

What participants receive

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

  • ALX1-11Drug

What is being measured

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

  1. The primary objective of this study is to evaluate the safety of continued once-daily dosing with 100 mg ALX1-11 in postmenopausal osteoporotic women who participated in TOP and OLES clinical trials.

    Measured: Throughout the study period of approximately 18 months.

Secondary outcomes (1)

  1. The secondary objective is to evaluate the continued efficacy of once-daily treatment with ALX1-11 for maintaining increases in bone mineral density (BMD).

    Measured: Throughout the study period of approximately 18 months.

Timeline

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

  1. First posted15 Sep 2005 (estimated)
  2. Study start10 Jan 2005
  3. Primary completion27 Oct 2006
  4. Study completion27 Oct 2006

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00172120
Sponsor's protocol ID
CL1-11-016
Acronym
TRES
Status last verified
May 2021
First submitted
12 Sep 2005
Last updated
17 May 2021
Results posted
No
Data monitoring committee
No

Publications

  • Zanchetta JR, Bogado CE, Cisari C, Aslanidis S, Greisen H, Fox J, Lems W. Treatment of postmenopausal women with osteoporosis with PTH(1-84) for 36 months: treatment extension study. Curr Med Res Opin. 2010 Nov;26(11):2627-33. doi: 10.1185/03007995.2010.524121. Epub 2010 Oct 5.

    PubMed 20923256

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ALX1-11 in people with Osteoporosis, run by Shire at 12 sites in 2 countries.

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 5 inclusion and 56 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 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Argentina. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The primary objective of this study is to evaluate the safety of continued once-daily dosing with 100 mg ALX1-11 in postmenopausal osteoporotic women who participated in TOP and OLES clinical trials. (time frame: Throughout the study period of approximately 18 months.). 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 NCT00172120, 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 17 May 2021.

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