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OsteoporosisPhase 3CAPNCT00172172

Calcium Supplementation in Postmenopausal Women

A Phase 3 study testing PTH/Calcium in people with Osteoporosis, run by Shire at 27 sites in 3 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

This study is evaluating the effects of calcium supplementation on the efficacy and safety of recombinant parathyroid hormone (ALX1-11) in postmenopausal women with osteoporosis. 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?
PTH/Calcium
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
374 participants
Where
27 sitesin 3 countries
Study dates
10 Jan 2004to 11 Mar 2005
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

  • Women who are capable of understanding and giving written, voluntary informed consent before the clinical study screening visit
  • Women with the ability to self-administer a daily injection or having a designee who will give the injections
  • Women who are postmenopausal with at least one year since their last menstruation. If a subject's menopausal status at screening is in question, because of history or because the subject had a hysterectomy without oophorectomy, a follicle-stimulating hormone (FSH) level >40 mIU/mL will satisfy the definition of postmenopausal status.
  • Women 45-54 years of age with the following T-score and/or vertebral fracture
  • T-score >=3.0 standard deviations (SD) below mean peak bone mass of young women at the lumbar spine, femoral neck, or total hip Or
  • T-score >=2.5 SD below mean peak bone mass of young women at the lumbar spine, femoral neck, or total hip with a prevalent vertebral fracture verified by the central imaging organization before the subject is enrolled into the study
Show all 12Show fewer
  • Women >=55 years of age with the following T-score and/or vertebral fracture:
  • o T-score >=2.5 SD below mean peak bone mass of young women at the lumbar spine, femoral neck, or total hip Or
  • T-score >=2.0 SD below mean peak bone mass of young women at the lumbar spine, femoral neck, or total hip with a vertebral fracture verified by the central imaging organization before the subject is enrolled into the study
  • The following types of vertebral fractures should not be considered for subject enrollment into this study:
  • Pathological fractures due to malignant disease or infection
  • Fractures due to excessive trauma sufficient to cause a fracture in young individuals with normal bone mass

Who cannot join

  • Vertebral Deformity (assessed as described in Appendix 2 of the protocol, are sufficient for exclusion):
  • Vertebral deformities
  • Patient has 5 or more vertebral (thoracic and lumbar) fractures
  • Patient has 2 or more lumbar vertebral deformities (L1 to L4)
  • DXA Imaging:
  • Inability to have a DXA scan performed, e.g.:
Show all 101Show fewer
  • A history of a lumbar laminectomy which interferes with the DXA measurement of the lumbar vertebrae
  • The presence of pedicle screws
  • The patient cannot lay flat on her back for the required time to provide accurate imaging
  • Patient is not able to have an A/P lumbar vertebral DXA performed
  • Patient has a history of vertebroplasty
  • Any other excessive degenerative disease which interferes with the DXA measurement of the lumbar vertebrae or hip
  • History of or Concurrent Illness:
  • Disorders of Immunity
  • HIV
  • Significant* immunological disorders
  • Endocrine system
  • Any history of hyper- or hypoparathyroidism
  • Cushing's disease
  • Hyperthyroidism (within 12 months)
  • Significant* endocrine disorders
  • Gastrointestinal system
  • Significant* gastrointestinal disorders
  • Kidney and collecting system
  • Clinically significant* history of nephrolithiasis or urolithiasis
  • Current impaired renal function and/or verified kidney calcification*
  • Significant* renal disorders
  • Liver, biliary tract and pancreatic systems
  • Active hepatitis or pancreatitis
  • Significant* hepatic or pancreatic disorders
  • Musculoskeletal system
  • Any history of other metabolic bone diseases within the past 5 years, (e.g., Paget´s disease, osteogenesis imperfecta, osteomalacia)
  • Subjects with chronic, active joint disease and/or joint infection
  • Neoplasia - Any history of bone cancer or any cancer within the previous 5 years, with the exception of squamous or basal cell carcinoma**
  • ()Patients who have had either squamous or basal cell carcinoma of the skin can enroll if:
  • The lesion(s) were fully resected with clear margins described in a written report by a pathologist, and
  • The patient has had no recurrence of lesions for at least one year from the time of the original resection.
  • Nervous system
  • Significant* neurological or psychiatric disease
  • Vascular, respiratory and cardiac system
  • 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.
  • Concurrent Medication:
  • Patients cannot be enrolled into this clinical trial if they have received any of the following therapies at any time:
  • Any PTH or PTH analogs [e.g., rhPTH(1-84), PTH(1-34), PTHrP and analogs]
  • Fluoride
  • Strontium
  • Patients must have been off the following agents for the specified times before entering the screening phase of this clinical trial:
  • Any investigational drug (>30 days)
  • Anabolic steroids or androgens (>6 consecutive months)
  • Active Vitamin D3 metabolites and analogs, e.g., calcitriol (>90 days)
  • Provera (medroxyprogesterone) (According to label instructions)
  • Systemic corticosteroids, more than 5mg/day formulation equivalent to 5mg/day prednisone (>12 consecutive month or as acute bolus for nonrecurring condition). A patient who has been enrolled in the study and needs to receive an acute bolus of steroids (oral or injectable) for a self-limited illness may continue treatment in the study if the following requirements are met:
  • The maximal dose of steroid (prednisone equivalent) is limited to no more than 225 mg (7.5 mg each day for 30 days)
  • The illness is acute in nature and is not expected to recur during the remaining treatment period of the study
  • Inhaled corticosteroids equivalent to <1200 μg of beclomethasone
  • Bisphosphonates, including investigational bisphosphonates
  • If the patient has received bisphosphonates for >90 days during 12 months immediately before screening, the patient is excluded from this study.
  • If the patient has received bisphosphonates for more than 12 months at any time.
  • The patient may be enrolled if she:
  • Has taken bisphosphonates for >=30 days but <=90 days, and has completed washout of equivalent time.
  • No washout is necessary if the patient has taken bisphosphonates <30 days.
  • Intravenous (IV) pamidronate
  • Patient can have received 1 dose of pamidronate in >3 to 12 months immediately preceding the screening visit. Patient should not have received this 1 dose within the three months immediately prior to the screening visit
  • Patient must not have received >2 doses at any time before screening.
  • Cyclical Etidronate
  • Patient should not have an exposure equal to 9 months on a standard dose (e.g., 400 mg).
  • Exposure to cyclical etidronate must be <=6 months on a standard dose (e.g., 400 mg/day) prior to the screening visit.
  • Phenytoin for seizure control:
  • If the patient has received phenytoin <5 years before, the patient is excluded from this study
  • The patient may continue in the screening process if:
  • >=15 years have passed since the last dose of phenytoin or if use was between 5-15 years before the screening visit and the patient received phenytoin for <2 months
  • Patients may be enrolled if they have been stabilized on the following therapy for the specified amount of time:
  • Thyroid Hormone (<0.1 mg/day thyroxine) therapy for >=6 months
  • If taking >= 0.1 mg/day but <= 0.2 mg/day, must have serum TSH level >= 0.1 mU/L. Patients will be excluded if they are taking doses of >0.2 mg/day.
  • If a patient has had a minimal change in L-thyroxine dose of <=0.025 mg/day within 6 months of enrollment, and has been on this new dose for >=2 months, she may continue. The patient must have the history documented with L-thyroxine in the CRF.
  • If a patient requires an increase or decrease in her thyroid replacement dose, after she has been enrolled in this clinical study, each increment or decrement should be <=0.025 mg/day, and increments should not occur more frequently than once per month, as recommended by a physician who is caring for the patient. The patient must have a TSH and thyroxine level within 3 months of the dose change to ensure that the patient does not become hyperthyroid, or hypothyroid.
  • Thiazide (Stable dosage of thiazide for >=3 consecutive months)
  • All patients must stop the following therapies at least 4 weeks before starting the stabilization period and will remain off these therapies for the remainder of the clinical study. The informed consent must be signed prior to the washout of any therapy. Screening laboratories must be performed only after the washout is complete. However, imaging studies (BMD, X-rays) may be performed prior to starting the calcitonin, estrogen, or Selective Estrogen Receptor Modulation (SERM) washout.
  • Calcitonin
  • Estrogen replacement therapy by oral, transdermal, or intramuscular administration
  • Vaginal application of estrogen-containing creams (If conjugated estrogen or estradiol: <=0.5 g twice each week [total of 1.0 g weekly] this medication is allowed)
  • SERM drugs, e.g., tamoxifen, raloxifene, Evista
  • Cytostatics, e.g., azathioprine, recombinant human tumor necrosis fusion (Fc) protein, monoclonal antibody against tumor necrosis factor (e.g., remicade [infliximab]
  • Medication known to affect the metabolism of bone (the Principal Investigator should discuss this with the PMO before the patient is excluded from enrollment).
  • Miscellaneous Concurrent Medications
  • Methotrexate,which interferes with DNA synthesis, repair and cellular replication.
  • Immunomodulatory agents with antiproliferative activity.
  • Intra-articular injections
  • Patients may receive a maximum of 1 intra-articular injection (ONE JOINT ONLY) every 6 months while participating in this study. The dose of corticosteroid injected should not exceed the anti-inflammatory equivalent dose of Prednisone 40-mg suspension. The dose and volume should be adjusted downward as appropriate to the size of the joint.
  • Laboratory Values and Physical Examination Findings:
  • -For laboratory values, the levels shown below are the upper limits for exclusions based on specific test results. For weight, the limit is the lower limit.
  • Serum calcium >10.7 mg/dL (>2.67 mmol/L)
  • Serum creatinine > 1.5 mg/dL (132.6 µmol/L)
  • Urinary calcium to creatinine ratio >=1.0 (mmol/mmol)
  • Total serum alkaline phosphatase >130 U/L (Serum total alkaline phosphatase value given is for the U.S.; >311 U/L (Argentina), >159 U/L (Mexico).
  • Body weight <40 kg
  • Substance Abuse:
  • Subjects are excluded for a history of alcohol and/or drug abuse as determined by the investigator
  • Compliance:
  • Subjects are excluded if they exhibit suspected or confirmed poor compliance in completing clinical study evaluations and/or clinical study required questionnaires.

Trial locations and contacts

27 sites in 3 countries.

27 sites in 3 countries

United States17 sites

  • Odyssey Research/Avera United Clinic

    Aberdeen, South Dakota, 57401

  • 'New Mexico Clinical Research and Osteoporosis Center

    Albuquerque, New Mexico, 87106

  • 'Bethesda Health Research Center

    Bethesda, Maryland, 20817

  • 'Odyssey Research Services

    Bismarck, North Dakota, 58501

  • 'The University of Chicago

    Chicago, Illinois, 60637

  • Odyssey Research/Bone Density of North Idaho

    Coeur d'Alene, Idaho, 83814

  • 'Michigan Bone & Mineral Clinic

    Detroit, Michigan, 48236

  • Michael J. Lillestol

    Fargo, North Dakota, 58103

  • 'University Hospital & Outpatient Center

    Indianapolis, Indiana, 46202

  • 'Radiant Research - Lake Worth

    Lake Worth, Florida, 33461

  • 'Diabetes Center of the Southwest

    Midland, Texas, 79705

  • 'Odyssey Research Services

    Minot, North Dakota, 58701

  • Odyssey Research

    North Platte, Nebraska, 69101

  • Creighton University School of Medicine

    Omaha, Nebraska, 68131

  • 'Boling Clinical Trials

    Rancho Cucamonga, California, 91730

  • 'Brown Clinic

    Watertown, South Dakota, 57201

  • 'Radiant Research

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Mexico8 sites

  • 'Hospital Clinical del Parque

    Chihuahua City, CHIH, 31020

  • 'OPD Hospital Civil de Guadalajara Dr. Juan I. Menchaca

    Guadalajara, Jalisco, 44340

  • 'Hospital Civil de Belem

    Guadalajara, Jalisco, 44650

  • 'Medica Monraz

    Guadalajara, Jalisco, 44670

  • 'Hospital Angeles de las Lomas

    Huixquilucan, EMEX, 52763

  • 'Hospital Aranda de la Parra

    León, Guanajuato, 37000

  • 'Instituto Mexicano de Investigacion Clinica

    Mexico City, Mexico City, 06700

  • 'Hospital Universitario de Monterrey

    Monterrey Nuevo Leon, 64040

Other trials in Mexico

Argentina2 sites

  • 'IDIM

    Buenos Aires, BUE, C1012AAR

  • 'Centro de Osteopatias Medicas

    Capital Federal, CBA, C1114AAI

Other trials in Argentina

About this study

Official title: A Study to Evaluate the Effects of Calcium Supplementation on the Efficacy and Safety of Recombinant Human Parathyroid Hormone (ALX1-11) in Postmenopausal Women With Osteoporosis (CAP Study)

This study is evaluating the effects of calcium supplementation on the efficacy and safety of recombinant parathyroid hormone (ALX1-11) in postmenopausal women with osteoporosis. The primary objective of this clinical study is to evaluate whether increases in bone mineral density (BMD) for subjects treated with ALX1-11 and receiving no calcium supplementation are less than increases in BMD observed for subjects treated with ALX1-11 and receiving calcium supplementation.

Read the detailed description

Effects of ALX1-11 on bone mineral density (BMD) have been documented in a dose-finding Phase II clinical trial in osteoporotic postmenopausal women, supplemented with calcium and Vitamin D3 but without any other treatment for osteoporosis. The anabolic effects of ALX1-11 in the lumbar vertebrae were statistically significant after the 12-month treatment period and more pronounced than any approved therapy. Additionally, animal studies have shown that the new bone formed by treatment with ALX1 11 is of good quality both histologically and biomechanically.

The primary objective of this clinical study is to evaluate whether increases in bone mineral density (BMD) for subjects treated with ALX1-11 and receiving no calcium supplementation are less than increases in BMD observed for subjects treated with ALX1-11 and receiving calcium supplementation.

A secondary objective of this clinical study are to evaluate whether changes in other efficacy parameters, such as bone mineral content (BMC) and biochemical markers of bone turnover, for subjects treated with ALX1-11 and receiving no calcium supplementation are less than increases observed for subjects treated with ALX1-11 and receiving calcium supplementation.

This is a double-blind, multi-centered, randomized, placebo-controlled, parallel-group study comprised of 3 treatment groups: ALX1-11 injection plus oral calcium, ALX1-11 injection plus oral placebo calcium, and placebo ALX1-11 injection plus oral calcium. All subjects also receive 400 IU oral vitamin D3. The dose of ALX1-11 to be used in this study is 100 μg, self administered by daily sc injection. The calcium dose is 700 mg/day.

Additional supplemental calcium and/or Vitamin D3 will not be permitted. Patients will be monitored for the development of hypercalcemia and/or hypercalciuria.

Conditions
Osteoporosis
Being tested
PTH/Calcium, PTH/placebo, placebo
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.

  • PTH/CalciumDrug

    Also called PREOS

    PTH(1-84) subcutaneous injection and calcium 700 mg oral

  • PTH/placeboDrug

    Also called PREOS

    PTH (1-84) injected subcutaneously and placebo provided orally

  • placeboDrug

    Placebo injected subcutaneously and 700 mg calcium orally

Study groups in NCT00172172
Study groupRoleWhat they receive
1ExperimentalPTH 100 mcg and 700 mg calcium
Receives: Drug: PTH/Calcium
2ExperimentalPTH 100 mcg and placebo
Receives: Drug: PTH/placebo
3Placebo comparatorPlacebo and 700 mg calcium
Receives: Drug: placebo

What is being measured

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

  1. Evaluate subjects treated with ALX1-11 (no calcium supplementation) increase in BMD is less than those treated with ALX1-11 (receiving calcium supplementation).

    Measured: 6 months

  2. Primary efficacy variable is the percentage change from baseline of lumbar vertebral BMDmeasured by DXA.

    Measured: 6 months

Secondary outcomes (16)

  1. BMC,

    Measured: 6 months

  2. vBMD,

    Measured: 6 months

  3. the incidence of clinical fractures,

    Measured: 6 months

  4. height,

    Measured: 6 months

  5. biochemical markers of bone turnover for subjects treated with ALX1-11 and receiving no calcium versus those receiving ALX1-11 with calcium supplementation.

    Measured: 6 months

  6. Adverse Events

    Measured: 6 months

  7. 12 lead ECG changes

    Measured: 6 months

  8. Percentage change from baseline of lumbar vertebral BMC

    Measured: 6 months

  9. Percentage change from baseline of total hip BMD and BMC

    Measured: 6 months

  10. Percentage change from baseline in biochemical markers of bone turnover: 1) Bone formation: Serum BSAP and P1NP 2) Bone resorption: Serum CTx, urinary NTx

    Measured: 6 months

  11. Incidence of new and/or worsened vertebral (thoracic and lumbar) fractures

    Measured: 6 months

  12. Incidence of any clinical fractures (vertebral and/or non-vertebral)

    Measured: 6 months

  13. Incidence of hip fractures

    Measured: 6 months

  14. Incidence of clinical fractures other than hip, or thoracic or lumbar vertebrae

    Measured: 6 months

  15. Percentage change from baseline of trabecular volumetric BMD of spine as assessed by QCT (sub-study)

    Measured: 6 months

  16. Percentage change from baseline of trabecular volumetric BMD of hip as assessed by QCT (sub-study)

    Measured: 6 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 2004
  3. Primary completion11 Mar 2005
  4. Study completion11 Mar 2005

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00172172
Sponsor's protocol ID
CL1-11-008
Acronym
CAP
Status last verified
May 2021
First submitted
13 Sep 2005
Last updated
25 May 2021
Results posted
No
Data monitoring committee
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PTH/Calcium in people with Osteoporosis, run by Shire at 27 sites in 3 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 12 inclusion and 101 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 25 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 27 sites in United States, Mexico, 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. Some participants in this study may receive a placebo. 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?

Evaluate subjects treated with ALX1-11 (no calcium supplementation) increase in BMD is less than those treated with ALX1-11 (receiving calcium supplementation). (time frame: 6 months). 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 NCT00172172.

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 25 May 2021.

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