Low Bone DensityNCT03761979

Safety and Pharmacokinetics of Orally Administered Strontium L-Lactate in Healthy Adults

A study testing Strontium L-lactate in people with Low Bone Density and Osteopenia, run by BioLink Life Sciences, Inc. at 1 site in United States.

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

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Low Bone Density, Osteopenia, Osteoporosis, Postmenopausal
What is being tested?: Strontium L-lactate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 9 Mar 2017to 17 Jul 2017
Phase: Interventional
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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject is a generally healthy male or female, 18-65 years of age, inclusive.
Subject has a score of 7 to l O on the Vein Access Scale at Visit l (day -7).
Subjects exhibits a body weight >60 kg and has a BMI of2:l 8.0 and <32.0 kg/m2 at Visit 1 (day -7).
Subject is willing to avoid use of any over-the-counter medications and/or dietary supplements (vitamins, minerals and/or other supplements) within 3 d prior to visit 1 (day-7) and/or prescription medications (except for stable-dose oral contraceptives) within 14 d prior to visit l (day -7) and throughout the study period.
Subject is willing to avoid alcohol 3 d prior to each test visit (Visits 2, 3, and 4; days 0, 7, and 14).
Subject is willing to avoid grapefruit and/or grapefruit juice 3 d prior to each test visit (Visits 2, 3, and 4; days 0, 7, and 14).

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Subject is willing to maintain habitual diet, physical activity patterns, and body weight throughout the trial.
Subject is a non-user of all tobacco, smoking products (including, but not limited to cigarettes, cigars, chewing tobacco, e-cigarettes), and nicotine products (e.g., nicotine gum and/or nicotine patches) within 6 months of Visit 1 (day -7) and has no plans to change status during the study period.
Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
l 0. Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.

Who cannot join

Subject has abnormal laboratory test results of clinical significance at Visit 1 (day -7) at the discretion of the Investigator. One re-test will be allowed on a separate day prior to Visit 2 (day 0), for subjects with abnormal laboratory test results.
Subject has a known allergy or sensitivity to any of the ingredients in the study products and/or any ingredients of the meals provided.
Subject has a history of anaphylaxis, a documented hypersensitivity reaction, and/or a clinically important reaction to any drug.
Subject has a history or presence of clinically important endocrine (including hyperparathyroidism, type l or 2 diabetes mellitus and/or hypoglycemia), cardiovascular (including, but not limited to history of myocardial infarction, peripheral arterial disease, stroke), pulmonary (including uncontrolled asthma), hepatic, renal, hematologic, immunologic, dermatologic, neurologic (such as Alzheimer's or Parkinson's patients), rheumatic (including gout), biliary, and/or psychiatric disorders (including depression and/or anxiety disorders), that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
Subject has had a loss of 400 mL of blood (e.g., blood/plasma donation) during the prior 30 d of visit 2 (day 0).
Subject has a history or current GI disorder that, in the judgment of the Investigator, may have the potential to disrupt normal digestion and absorption.

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Subject has a history or presence of cancer in the prior two years, except for non- melanoma skin cancer.
Subject has a history of bariatric surgery for weight reducing purposes.
Subject has recently (within 6 months prior to Visit 1; day -7) had a weight loss or gain >4.5 kg.
I 0. Subject has uncontrolled hypertension (systolic blood pressure 2:160 mm Hg or diastolic blood pressure 2:100 mm Hg) as defined by the blood pressure measured at Visit 1 (day -7). One re-test will be allowed on a separate day prior to Visit 2 (day 0), for subjects with abnormal blood pressure.
11. Subject has extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian, intentional consumption of a high fiber diet), in the opinion of the Clinical Investigator.
12. Subject is a female, who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
13. Subject has been exposed to any non-registered drug product within 30 d prior to visit I (day-7).
14. Subject has a recent history of (within 12 months of screening; Visit I; day -7) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink= 12 oz beer, 5 oz wine, or I Yi oz distilled spirits).
15. Individual has a condition the Clinical Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.

Trial locations and contacts

1 site in 1 country.

United States1 site

Biofortis Innovation Services
Addison, Illinois, 60101

Other trials in United States

About this study

No clinical trials have evaluated strontium L-lactate (SrLac), the strontium salt of the L-enantiomer of lactic acid. Therefore, this clinical study was conducted to obtain general safety and pharmacokinetic (PK) information following acute oral intakes of three doses of SrLac by healthy adults. The data provided valuable comparisons with the pharmacokinetics of other strontium salts that are in clinical use and allowed determination of the dose of SrLac that will be useful for the management of bone health.neficial for the treatment of low bone density of osteoporosis and osteopenia.

Read the detailed description

Purpose: The aim of this clinical study was to obtain safety and pharmacokinetic information following acute oral intakes of three ascending doses of strontium L-lactate by healthy adults.

Subjects and methods: Ten healthy men and women, mean age 43 ± 2 years, ingested one of three ascending doses of strontium L-lactate (SrLac) once per week for three weeks in succession. Fasting blood collections were performed pre-dose and 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose for determination of serum strontium at each interval.

Conditions: Low Bone Density, Osteopenia, Osteoporosis, Postmenopausal
Being tested: Strontium L-lactate
Keywords: Bone density, Osteopenia, Osteoporosis, Bone health, Pharmacokinetics
Medical subject headings: Bone Diseases, Metabolic, Osteoporosis, Postmenopausal, Osteoporosis

What participants receive

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

Strontium L-lactateDietary supplement
Also called SrLac
The Study Product was a highly pure form of SrLac, the strontium salt of L-lactic acid. SrLac was manufactured in compliance with current Good Manufacturing Practices. SrLac was thoroughly tested and met rigorous purity specifications. It was free from contamination by D-lactic acid and trace metals known to harm human health.

Study groups in NCT03761979
Study group	Role	What they receive
Strontium dose of 170 mg	Active comparator	The Sponsor provided each 170 mg dose of strontium as strontium L-lactate dry powder packaged in individual vials. The powder was prepared for consumption by adding 10 mL of distilled water to the vial and stirring until dissolution was complete. This liquid was then poured into an administration cup. An additional 10 mL of distilled water was used to rinse the remaining SrLac into the administration cup. Then 80 mL of distilled water was added directly into the administration cup. Following consumption of the 100 mL solution of SrLac, another 100 mL of distilled water was added into the administration cup, swirled, and consumed by the subject. Receives: Dietary Supplement: Strontium L-lactate
strontium dose of 340 mg	Active comparator	The Sponsor provided each 340 mg dose of strontium as strontium L-lactate dry powder packaged in individual vials. The powder was prepared for consumption by adding 10 mL of distilled water to the vial and stirring until dissolution was complete. This liquid was then poured into an administration cup. An additional 10 mL of distilled water was used to rinse the remaining SrLac into the administration cup. Then 80 mL of distilled water was added directly into the administration cup. Following consumption of the 100 mL solution of SrLac, another 100 mL of distilled water was added into the administration cup, swirled, and consumed by the subject. Receives: Dietary Supplement: Strontium L-lactate
Strontium dose of 680 mg	Active comparator	The Sponsor provided each 680 mg dose of strontium as strontium L-lactate dry powder packaged in individual vials. The powder was prepared for consumption by adding 10 mL of distilled water to the vial and stirring until dissolution was complete. This liquid was then poured into an administration cup. An additional 10 mL of distilled water was used to rinse the remaining SrLac into the administration cup. Then 80 mL of distilled water was added directly into the administration cup. Following consumption of the 100 mL solution of SrLac, another 100 mL of distilled water was added into the administration cup, swirled, and consumed by the subject. Receives: Dietary Supplement: Strontium L-lactate

What is being measured

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

iAUC-0.25-12h
The primary outcome variable was the incremental area under the curve (iAUC) for serum strontium from pre-product consumption (t = -0.25 h) to 12 h (iAUC-0.25-12h).
Measured: 0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing

Secondary outcomes (6)

(iAUC-0.25-∞)
iAUC for serum strontium from pre-product consumption (t = -0.25 h) to infinity (iAUC-0.25-∞)
Measured: 0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing
Cmax
Maximum serum concentration (Cmax)
Measured: 0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing
Tmax
Time to Cmax (Tmax)
Measured: 0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing
K
Rate of elimination (K)
Measured: 0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing
t1/2
Half life (t1/2)
Measured: 0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing
Oral bioavailability (F)
The fraction of the amount of strontium given orally that reaches the systemic circulation
Measured: 0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing

Timeline

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

9 Mar 201717 Jul 2017

First posted3 Dec 2018
Study start9 Mar 2017
Primary completion1 Jun 2017
Study completion17 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Low Bone DensityStudies 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 N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Model description: This was an unblinded, sequential, three dose study. The study consisted of one screening visit (Visit 1; day -7) and three test visits (Visits 2, 3, and 4; days 0, 7, and 14) with at least a 6-d washout between test visits.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03761979
Sponsor's protocol ID: BIO-1703
Status last verified: Nov 2018
First submitted: 29 Nov 2018
Last updated: 3 Dec 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Study data will be shared as needed to complete Institutional Review Board (IRB) reviews, enable statistical analyses, and prepare study reports.

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 Low Bone Density trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Pharmacokinetics of Orally Administered Strontium L-Lactate in Healthy Adults
ClinicalTrials.gov ID: NCT03761979
Acronym / sponsor ID: BIO-1703
Conditions: Low Bone Density, Osteopenia, Osteoporosis, Postmenopausal
Keywords: Bone density, Osteopenia, Osteoporosis, Bone health, Pharmacokinetics
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: BioLink Life Sciences, Inc.Industry (pharma, biotech, devices)
Collaborators: Biofortis Innovation Services, NMS Laboratories
Study start: 9 Mar 2017 (actual)
Primary completion: 1 Jun 2017 (actual)
Study completion: 17 Jul 2017 (actual)
First posted: 3 Dec 2018 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Purpose: The aim of this clinical study was to obtain safety and pharmacokinetic information following acute oral intakes of three ascending doses of strontium L-lactate by healthy adults.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3
Model description: This was an unblinded, sequential, three dose study. The study consisted of one screening visit (Visit 1; day -7) and three test visits (Visits 2, 3, and 4; days 0, 7, and 14) with at least a 6-d washout between test visits.

Arm	Type	Receives
Strontium dose of 170 mg	Active comparator	Dietary Supplement: Strontium L-lactateThe Sponsor provided each 170 mg dose of strontium as strontium L-lactate dry powder packaged in individual vials. The powder was prepared for consumption by adding 10 mL of distilled water to the vial and stirring until dissolution was complete. This liquid was then poured into an administration cup. An additional 10 mL of distilled water was used to rinse the remaining SrLac into the administration cup. Then 80 mL of distilled water was added directly into the administration cup. Following consumption of the 100 mL solution of SrLac, another 100 mL of distilled water was added into the administration cup, swirled, and consumed by the subject.
strontium dose of 340 mg	Active comparator	Dietary Supplement: Strontium L-lactateThe Sponsor provided each 340 mg dose of strontium as strontium L-lactate dry powder packaged in individual vials. The powder was prepared for consumption by adding 10 mL of distilled water to the vial and stirring until dissolution was complete. This liquid was then poured into an administration cup. An additional 10 mL of distilled water was used to rinse the remaining SrLac into the administration cup. Then 80 mL of distilled water was added directly into the administration cup. Following consumption of the 100 mL solution of SrLac, another 100 mL of distilled water was added into the administration cup, swirled, and consumed by the subject.
Strontium dose of 680 mg	Active comparator	Dietary Supplement: Strontium L-lactateThe Sponsor provided each 680 mg dose of strontium as strontium L-lactate dry powder packaged in individual vials. The powder was prepared for consumption by adding 10 mL of distilled water to the vial and stirring until dissolution was complete. This liquid was then poured into an administration cup. An additional 10 mL of distilled water was used to rinse the remaining SrLac into the administration cup. Then 80 mL of distilled water was added directly into the administration cup. Following consumption of the 100 mL solution of SrLac, another 100 mL of distilled water was added into the administration cup, swirled, and consumed by the subject.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Subject is a generally healthy male or female, 18-65 years of age, inclusive.
Subject has a score of 7 to l O on the Vein Access Scale at Visit l (day -7).
Subjects exhibits a body weight >60 kg and has a BMI of2:l 8.0 and <32.0 kg/m2 at Visit 1 (day -7).
Subject is willing to avoid use of any over-the-counter medications and/or dietary supplements (vitamins, minerals and/or other supplements) within 3 d prior to visit 1 (day-7) and/or prescription medications (except for stable-dose oral contraceptives) within 14 d prior to visit l (day -7) and throughout the study period.
Subject is willing to avoid alcohol 3 d prior to each test visit (Visits 2, 3, and 4; days 0, 7, and 14).

Key exclusion criteria (15 listed)

Subject has abnormal laboratory test results of clinical significance at Visit 1 (day -7) at the discretion of the Investigator. One re-test will be allowed on a separate day prior to Visit 2 (day 0), for subjects with abnormal laboratory test results.
Subject has a known allergy or sensitivity to any of the ingredients in the study products and/or any ingredients of the meals provided.
Subject has a history of anaphylaxis, a documented hypersensitivity reaction, and/or a clinically important reaction to any drug.
Subject has a history or presence of clinically important endocrine (including hyperparathyroidism, type l or 2 diabetes mellitus and/or hypoglycemia), cardiovascular (including, but not limited to history of myocardial infarction, peripheral arterial disease, stroke), pulmonary (including uncontrolled asthma), hepatic, renal, hematologic, immunologic, dermatologic, neurologic (such as Alzheimer's or Parkinson's patients), rheumatic (including gout), biliary, and/or psychiatric disorders (including depression and/or anxiety disorders), that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
Subject has had a loss of 400 mL of blood (e.g., blood/plasma donation) during the prior 30 d of visit 2 (day 0).

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
Strontium L-lactateAlso: SrLacThe Study Product was a highly pure form of SrLac, the strontium salt of L-lactic acid. SrLac was manufactured in compliance with current Good Manufacturing Practices. SrLac was thoroughly tested and met rigorous purity specifications. It was free from contamination by D-lactic acid and trace metals known to harm human health.	Dietary supplement	Strontium dose of 170 mg, Strontium dose of 680 mg, strontium dose of 340 mg

Primary outcome

iAUC-0.25-12h
Time frame: 0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing
The primary outcome variable was the incremental area under the curve (iAUC) for serum strontium from pre-product consumption (t = -0.25 h) to 12 h (iAUC-0.25-12h).

6 secondary outcomes

(iAUC-0.25-∞)
Time frame: 0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing
Cmax
Time frame: 0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing
Tmax
Time frame: 0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing
K
Time frame: 0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing
t1/2
Time frame: 0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing
Oral bioavailability (F)
Time frame: 0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
Individual participant dataSharing planned: Yes. Study data will be shared as needed to complete Institutional Review Board (IRB) reviews, enable statistical analyses, and prepare study reports.

Related trials for Low Bone Density

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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.

Kristin Sanoshy study director

Biofortis Innovation Services

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

Questions about this trial

What is this clinical trial studying?

A study testing Strontium L-lactate in people with Low Bone Density and Osteopenia, run by BioLink Life Sciences, Inc. at 1 site in United States.

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 15 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 3 Dec 2018. 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 States. 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.

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?

iAUC-0.25-12h (time frame: 0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing). 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 NCT03761979.

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 3 Dec 2018.