Fortical

Hypercalcemia, Osteoporotic Fractures, Osteoporosis + 5 more

Treatment

20 Active Studies for Fortical

What is Fortical

Salmon calcitonin

The Generic name of this drug

Treatment Summary

Nasal spray containing a 32-amino acid chain, a type of protein.

Miacalcin

is the brand name

image of different drug pills on a surface

Fortical Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Miacalcin

Salmon calcitonin

1986

16

Effectiveness

How Fortical Affects Patients

Calcitonin helps increase bone mass and reduce the amount of calcium in the blood. It also increases the amount of certain minerals that the kidneys flush out, like calcium, phosphate, sodium, magnesium, and potassium. This results in more water, sodium, potassium, and chloride being released into the intestine.

How Fortical works in the body

Calcitonin helps to increase bone density by attaching itself to cells in your bones. This triggers a reaction that produces enzymes that help your body keep more calcium. It also helps your bones by activating a pathway that helps retain calcium.

When to interrupt dosage

The proposed dose of Fortical is contingent upon the ascertained condition, such as Osteoporosis, Postmenopause and Hypercalcemia. The measure of dosage may vary, depending on the technique of delivery (e.g. Injection, solution or Intramuscular; Subcutaneous) featured in the table beneath.

Condition

Dosage

Administration

Immobilization

, 200.0 [iU], 2200.0 [iU]/mL, 20000.0 [iU]/mL, 200.0 [iU]/mL, 100.0 [iU], 200.0 [USP'U]/mL, 200.0 units/mL, 200.0 units/pump actuation, 100.0 units/mL, 200.0 units/spray

, Nasal, Spray, metered, Spray, metered - Nasal, Injection, solution, Intramuscular, Injection, solution - Intramuscular, Intramuscular; Intravenous; Subcutaneous, Injection, solution - Intramuscular; Intravenous; Subcutaneous, Injection, solution - Intramuscular; Subcutaneous, Intramuscular; Subcutaneous, Liquid, Spray, Solution - Nasal, Solution, Solution - Intramuscular; Subcutaneous, Liquid - Intramuscular; Subcutaneous, Spray - Nasal, Liquid - Nasal, Liquid - Intramuscular; Intravenous; Subcutaneous

Postmenopause

, 200.0 [iU], 2200.0 [iU]/mL, 20000.0 [iU]/mL, 200.0 [iU]/mL, 100.0 [iU], 200.0 [USP'U]/mL, 200.0 units/mL, 200.0 units/pump actuation, 100.0 units/mL, 200.0 units/spray

, Nasal, Spray, metered, Spray, metered - Nasal, Injection, solution, Intramuscular, Injection, solution - Intramuscular, Intramuscular; Intravenous; Subcutaneous, Injection, solution - Intramuscular; Intravenous; Subcutaneous, Injection, solution - Intramuscular; Subcutaneous, Intramuscular; Subcutaneous, Liquid, Spray, Solution - Nasal, Solution, Solution - Intramuscular; Subcutaneous, Liquid - Intramuscular; Subcutaneous, Spray - Nasal, Liquid - Nasal, Liquid - Intramuscular; Intravenous; Subcutaneous

Paget’s Disease

, 200.0 [iU], 2200.0 [iU]/mL, 20000.0 [iU]/mL, 200.0 [iU]/mL, 100.0 [iU], 200.0 [USP'U]/mL, 200.0 units/mL, 200.0 units/pump actuation, 100.0 units/mL, 200.0 units/spray

, Nasal, Spray, metered, Spray, metered - Nasal, Injection, solution, Intramuscular, Injection, solution - Intramuscular, Intramuscular; Intravenous; Subcutaneous, Injection, solution - Intramuscular; Intravenous; Subcutaneous, Injection, solution - Intramuscular; Subcutaneous, Intramuscular; Subcutaneous, Liquid, Spray, Solution - Nasal, Solution, Solution - Intramuscular; Subcutaneous, Liquid - Intramuscular; Subcutaneous, Spray - Nasal, Liquid - Nasal, Liquid - Intramuscular; Intravenous; Subcutaneous

Hypercalcemia

, 200.0 [iU], 2200.0 [iU]/mL, 20000.0 [iU]/mL, 200.0 [iU]/mL, 100.0 [iU], 200.0 [USP'U]/mL, 200.0 units/mL, 200.0 units/pump actuation, 100.0 units/mL, 200.0 units/spray

, Nasal, Spray, metered, Spray, metered - Nasal, Injection, solution, Intramuscular, Injection, solution - Intramuscular, Intramuscular; Intravenous; Subcutaneous, Injection, solution - Intramuscular; Intravenous; Subcutaneous, Injection, solution - Intramuscular; Subcutaneous, Intramuscular; Subcutaneous, Liquid, Spray, Solution - Nasal, Solution, Solution - Intramuscular; Subcutaneous, Liquid - Intramuscular; Subcutaneous, Spray - Nasal, Liquid - Nasal, Liquid - Intramuscular; Intravenous; Subcutaneous

Osteoporotic Fractures

, 200.0 [iU], 2200.0 [iU]/mL, 20000.0 [iU]/mL, 200.0 [iU]/mL, 100.0 [iU], 200.0 [USP'U]/mL, 200.0 units/mL, 200.0 units/pump actuation, 100.0 units/mL, 200.0 units/spray

, Nasal, Spray, metered, Spray, metered - Nasal, Injection, solution, Intramuscular, Injection, solution - Intramuscular, Intramuscular; Intravenous; Subcutaneous, Injection, solution - Intramuscular; Intravenous; Subcutaneous, Injection, solution - Intramuscular; Subcutaneous, Intramuscular; Subcutaneous, Liquid, Spray, Solution - Nasal, Solution, Solution - Intramuscular; Subcutaneous, Liquid - Intramuscular; Subcutaneous, Spray - Nasal, Liquid - Nasal, Liquid - Intramuscular; Intravenous; Subcutaneous

Osteoporosis

, 200.0 [iU], 2200.0 [iU]/mL, 20000.0 [iU]/mL, 200.0 [iU]/mL, 100.0 [iU], 200.0 [USP'U]/mL, 200.0 units/mL, 200.0 units/pump actuation, 100.0 units/mL, 200.0 units/spray

, Nasal, Spray, metered, Spray, metered - Nasal, Injection, solution, Intramuscular, Injection, solution - Intramuscular, Intramuscular; Intravenous; Subcutaneous, Injection, solution - Intramuscular; Intravenous; Subcutaneous, Injection, solution - Intramuscular; Subcutaneous, Intramuscular; Subcutaneous, Liquid, Spray, Solution - Nasal, Solution, Solution - Intramuscular; Subcutaneous, Liquid - Intramuscular; Subcutaneous, Spray - Nasal, Liquid - Nasal, Liquid - Intramuscular; Intravenous; Subcutaneous

Osteitis Deformans

, 200.0 [iU], 2200.0 [iU]/mL, 20000.0 [iU]/mL, 200.0 [iU]/mL, 100.0 [iU], 200.0 [USP'U]/mL, 200.0 units/mL, 200.0 units/pump actuation, 100.0 units/mL, 200.0 units/spray

, Nasal, Spray, metered, Spray, metered - Nasal, Injection, solution, Intramuscular, Injection, solution - Intramuscular, Intramuscular; Intravenous; Subcutaneous, Injection, solution - Intramuscular; Intravenous; Subcutaneous, Injection, solution - Intramuscular; Subcutaneous, Intramuscular; Subcutaneous, Liquid, Spray, Solution - Nasal, Solution, Solution - Intramuscular; Subcutaneous, Liquid - Intramuscular; Subcutaneous, Spray - Nasal, Liquid - Nasal, Liquid - Intramuscular; Intravenous; Subcutaneous

Therapeutic procedure

, 200.0 [iU], 2200.0 [iU]/mL, 20000.0 [iU]/mL, 200.0 [iU]/mL, 100.0 [iU], 200.0 [USP'U]/mL, 200.0 units/mL, 200.0 units/pump actuation, 100.0 units/mL, 200.0 units/spray

, Nasal, Spray, metered, Spray, metered - Nasal, Injection, solution, Intramuscular, Injection, solution - Intramuscular, Intramuscular; Intravenous; Subcutaneous, Injection, solution - Intramuscular; Intravenous; Subcutaneous, Injection, solution - Intramuscular; Subcutaneous, Intramuscular; Subcutaneous, Liquid, Spray, Solution - Nasal, Solution, Solution - Intramuscular; Subcutaneous, Liquid - Intramuscular; Subcutaneous, Spray - Nasal, Liquid - Nasal, Liquid - Intramuscular; Intravenous; Subcutaneous

Warnings

There are 20 known major drug interactions with Fortical.

Common Fortical Drug Interactions

Drug Name

Risk Level

Description

Abacavir

Minor

Salmon calcitonin may decrease the excretion rate of Abacavir which could result in a higher serum level.

Acetaminophen

Minor

Salmon calcitonin may decrease the excretion rate of Acetaminophen which could result in a higher serum level.

Acetohexamide

Minor

The therapeutic efficacy of Acetohexamide can be decreased when used in combination with Salmon calcitonin.

Aclidinium

Minor

Salmon calcitonin may decrease the excretion rate of Aclidinium which could result in a higher serum level.

Acrivastine

Minor

Salmon calcitonin may decrease the excretion rate of Acrivastine which could result in a higher serum level.

Fortical Toxicity & Overdose Risk

Pregnant women, nursing mothers, and those with a history of allergies should be careful when taking salmon calcitonin, as it may reduce fetal weight in animals. Allergy reactions may also occur, such as difficulty breathing, swelling of the tongue or throat, and anaphylaxis. The manufacturer has reported an increased risk (from 0.7% to 2.4%) of cancer when taking salmon calcitonin orally compared to placebo. Other side effects may include nausea, rhinitis, headaches, and back pain.

Fortical Novel Uses: Which Conditions Have a Clinical Trial Featuring Fortical?

57 active trials are being conducted to assess the potential of Fortical to facilitate Therapeutic procedures, address Postmenopause symptoms and treat Osteitis Deformans.

Condition

Clinical Trials

Trial Phases

Hypercalcemia

1 Actively Recruiting

Phase 4

Immobilization

0 Actively Recruiting

Paget’s Disease

0 Actively Recruiting

Osteoporotic Fractures

3 Actively Recruiting

Phase 4, Not Applicable

Osteoporosis

28 Actively Recruiting

Not Applicable, Phase 4, Phase 1, Phase 3, Phase 2

Osteitis Deformans

0 Actively Recruiting

Postmenopause

5 Actively Recruiting

Phase 2, Not Applicable

Therapeutic procedure

0 Actively Recruiting

Fortical Reviews: What are patients saying about Fortical?

5

Patient Review

12/14/2010

Fortical for Decreased Bone Mass Following Menopause

This medication is prescribed for bone loss prior to menopause. It's great because it will actually grow back! After using it for two years and taking 1200mg of calcium daily, 50% of my bone loss had grown back. Another generic brand, calcitonin spray; the sprayer jams after only 2 weeks of usage.

5

Patient Review

5/28/2011

Fortical for Decreased Bone Mass Following Menopause

This was simple to use and the only downside was a bit of nose irritation.

4

Patient Review

2/14/2009

Fortical for Decreased Bone Mass Following Menopause

I've only been using this medication for a week or so, but I'm already seeing some benefits. My nose is less runny and there's less crusting.

3.3

Patient Review

9/21/2007

Fortical for Decreased Bone Mass Following Menopause

3

Patient Review

2/23/2010

Fortical for Decreased Bone Mass Following Menopause

I took Fortical a total of four times and now experience burning sensations when urinating. As a result, I have discontinued use of the medication.

3

Patient Review

9/14/2009

Fortical for Decreased Bone Mass Following Menopause

After I fractured and compressed a thoracic vertebra in an accident, my doctor prescribed this medication.

2.7

Patient Review

3/29/2013

Fortical for Decreased Bone Mass Following Menopause

I've been using Fortical for almost four years now. However, after my most recent bone scan results, it appears that the condition of my bones have worsened since I started taking the medication. My doctor wants me to try a different drug now. Other than that, I liked how easy this drug was to take and didn't experience any side effects.

2.3

Patient Review

3/25/2012

Fortical for Decreased Bone Mass Following Menopause

My bone density results have improved after using this drug for two years. I was diagnosed with osteopenia before starting the medication, and now my doctors say that I no longer have it.

2

Patient Review

9/27/2009

Fortical for Decreased Bone Mass Following Menopause

I found that a combination of weight-bearing exercises, calcium supplements, and Fortical helped to reverse my bone loss from osteopenia to normal. However, I don't think that any of these treatments would have been enough on their own.

1.7

Patient Review

11/2/2012

Fortical for Decreased Bone Mass Following Menopause

I used Fortical for almost a year, and started getting nosebleeds soon after starting. I had to keep stopping so they could heal, but they never did. I finally discontinued use, and now almost a year later I'm still dealing with the sores.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about fortical

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Miacalcin nasal spray used for?

"The text is saying that calcitonin is a nasal spray and injection used to treat osteoporosis in postmenopausal females, Paget's disease of bone, and high calcium, but it is not the best option."

Answered by AI

What is fortical pills used for?

"This drug is used to manage osteoporosis in women who are at least 5 years post-menopausal. Calcitonin helps to prevent bone loss and maintain strong bones, which decreases the likelihood of fractures."

Answered by AI

How does calcitonin nasal spray work?

"The purpose of calcitonin salmon nasal spray is to reduce the rate at which bones are broken down by cells called osteoclasts, and to encourage cells called osteoblasts to rebuild bones. This increases the density of bone in the lower spine."

Answered by AI

How long can you take calcitonin?

"Calcitonin helps to prevent bone loss when a person is immobilized for a short period of time following an osteoporotic fracture."

Answered by AI

Clinical Trials for Fortical

Image of UC San Diego in San Diego, United States.

Epione Device for Bone Conditions

18+
All Sexes
San Diego, CA

The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults. The main question is the determination of the rate of feasible procedures assisted by the Epione device Participants will undergo their procedure(s) as planned by their physician. If they accept to participate to the study, the differences with standard of care will be: * The use of the Epione device to place the introducer(s), instead of freehand placement if they do not participate * Additional CT or CBCT scans during the procedure.

Waitlist Available
Has No Placebo

UC San Diego (+2 Sites)

Sean Tutton, MD

Quantum Surgical

Image of University of Waterloo in Waterloo, Canada.

Virtual Chiropractic Intervention for Spinal Fracture

18+
All Sexes
Waterloo, Canada

This study will determine feasibility of a chiropractor delivered virtual intervention for individuals following osteoporotic vertebral fracture. This pilot trial will have two parallel groups with a 1:1 ratio. Participants will be randomized to: 1) immediate receipt; or 2) waitlist usual care control and delayed receipt of VIVA 10 weeks post-randomization. VIVA is an intervention for people with vertebral fractures that covers four areas: pain management, safe movement, exercise, and nutrition. It includes print and video resources, and a framework for goal setting, selecting exercises, and teaching body mechanics. A chiropractor (DC) completes a virtual assessment and then leads twelve 1:1 virtual sessions (via Zoom) over eight weeks. Sessions start with brief education on a topic (e.g., safe movement, pain management, exercise, nutrition), followed by training and modeling of exercise and safe movement strategies, then goal setting, and action planning. This trial will be considered feasible if a) we recruit 14 people in eight months; b) 80% of participants complete the trial; and c) exercise adherence is 75%.

Recruiting
Has No Placebo

University of Waterloo

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Image of Don tyson Center for Agricultural Sciencers in Fayetteville, United States.

Protein and Exercise for Postmenopausal Women

Any Age
Female
Fayetteville, AR

The goal of this clinical trial is to learn if consuming a higher protein diet that includes one serving of beef each day, in combination with resistance exercise, improves wellbeing in postmenopausal women. It will also tell us about how higher protein intake changes body composition and blood values related to health. The main questions it aims to answer are: * Does higher protein intake combined with resistance training improve mood and sleep in postmenopausal women? * What other health benefits to postmenopausal women experience when the follow a higher protein diet and participate in resistance exercise? Researchers will compare three groups 1) postmenopausal women living their daily lives as usual, 2) postmenopausal women consuming a higher protein diet, and 2) postmenopausal women consuming a higher protein diet and participating in resistance training. Participants will: * Consume a higher protein diet for 16 weeks * Participate in an at-home resistance training for 16 weeks * Keep a diary of their food intake, sleep habits, and mood * Have health assessments every 4 weeks

Recruiting
Has No Placebo

Don tyson Center for Agricultural Sciencers (+1 Sites)

Jamie Baum

Image of The Buck Institute for Research on Aging in Novato, United States.

GLYLO Supplement for Postmenopausal Aging

45 - 65
Female
Novato, CA

The aim of this study is to assess the effectiveness of GLYLO, a dietary supplement, in postmenopausal women aged 45 to 65 who are overweight or obese and have elevated HbA1c levels. Specifically, the study seeks to evaluate whether GLYLO can reduce advanced glycation end products (AGEs) levels, which are harmful compounds formed when sugar attaches to proteins or fats in the body and can contribute to aging and disease. The primary outcome of the study is to determine if GLYLO reduces AGEs, enhances metabolic and hormonal health, and mitigates age-related functional decline. This study includes one screening visit and three testing visits over a 6-month period. After eligibility is confirmed, participants will be randomly assigned to one of two groups to take either GLYLO (two capsules daily) or a placebo at home for 24 weeks. Participants will provide blood samples at every visit. During the three testing visits, they will complete physical performance and cognitive function tests, provide both blood and urine samples, and fill out quality of life and 24-hour dietary intake questionnaires. The dietary intake questionnaires will be completed only twice i.e. at the baseline visit and again at the final 6-month visit.

Recruiting
Advanced

The Buck Institute for Research on Aging

Image of University of Maryland, Baltimore, Department of Epidemiology and Public Health, Division of Gerontology in Baltimore, United States.

OPTIONS Program for Osteoporosis

65+
All Sexes
Baltimore, MD

Osteoporosis is a disease that weakens bones so the bones may break easily. The risk for osteoporosis increases with age in both women and men. Osteoporosis affects 10 million older adults in the US. Osteoporosis is a common cause of broken bones in the hips and legs. Broken bones can lead to disability, nursing home placement, and death. Because of the dire consequences, a broken hip or leg is one of the most dreaded injuries for older adults. Many studies confirm that a simple regimen of exercise, healthy diet and bone-strengthening medications can improve overall recovery after a broken hip or leg. This regimen can prevent a person from becoming disabled, having future fractures, and even prevent death. Many older adults have surgery in a hospital after breaking a hip or leg. Then older adults go to a skilled nursing facility (SNF) for rehabilitation. Care in SNFs varies greatly. Some patients do not receive the regimen that the investigators know is most beneficial to improve bone health and recovery. Even patients who get exercise, healthy diet, and bone-strengthening medication in the SNF, may not continue with the regimen once patients go home. Therefore, the investigators want to implement and test OsteoPorotic fracTure preventION System (OPTIONS). OPTIONS is a program that will integrate the regimen into the care that is provided in SNFs and after discharge to the community. OPTONS will provide information about exercise, diet, and bone-strengthening medication. OPTIONS will provide doctors, clinical staff, patients, and care partners with the information these stakeholders need to carry out the best-practice regimen. The investigators are partnering with PointClickCare, a large cloud-based healthcare software provider, with SNFs and community care sites across the US. The investigators will include 32 SNFs from different US areas. The investigators will flip a coin to assign SNFs to the intervention (OPTIONS) or the control arm (enhanced usual care) of the study. Enhanced usual care is the care that is typically provided in SNFs after a fracture and adding information about a publicly available fall prevention toolkit. The investigators are using an "implementation science" approach that requires the investigators to get input from the OPTIONS study's vast stakeholder community throughout the study. The OPTIONS study's stakeholders include patients, care partners, clinicians, and professional organizations. The research question is, can using OPTIONS in SNFs and in the community after discharge improve physical function and quality of life in older people in the year after a hip or leg fracture? The investigators are measuring patient-reported outcomes. The investigators will include 1553 patients across the 32 facilities. The investigators have selected outcomes that are important to patients. Specifically, the investigators are measuring patient-reported function and quality of life. The investigators are also measuring patient-reported falls and fractures. The investigators will track the number of patients who die during the study. This study's hypothesis is that patients who receive OPTIONS will report better physical function (i.e., can walk and take better care of themselves) than those who receive enhanced usual care. The investigators also hypothesize that patients that receive OPTIONS will report a better quality of life than those who receive enhanced usual care. This study will provide sound data about the effectiveness of OPTIONS. OPTIONS could then be spread to other SNFs and community-based programs. This would ensure that all older people receive the right care after a hip or leg fracture.

Waitlist Available
Has No Placebo

University of Maryland, Baltimore, Department of Epidemiology and Public Health, Division of Gerontology (+1 Sites)

Denise Orwig, PhD

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Virtual Rehabilitation for Spinal Fracture

18+
All Sexes
Vancouver, Canada

Spine fractures are the most common fracture due to osteoporosis. They happen during falls or activities of daily life, like bending to tie shoes. Fractures of the spine can result in pain, which can sometimes last for a long time. Spine fractures can affect breathing, appetite, digestion, and mobility, and can restrict or modify people's work or daily activities. There are no standard rehabilitation programs after spine fracture, and patients often have to pay for rehabilitation. Rehabilitation can be hard to access, especially in rural or remote locations. It can be hard to find health care or rehabilitation providers who specialize in treating spine fractures. After reviewing research and consulting patients and health care providers to understand their experiences with spine fracture rehabilitation, the research team developed a toolkit for a virtual rehabilitation program for people with spine fractures, called VIVA. The research team wants to submit a grant for a clinical trial to implement VIVA in five provinces and determine if VIVA reduces pain and improves physical functioning and quality of life, and if the benefits outweigh the costs. Before this, the team proposes to do a pilot study to test how feasible it is to do a study of VIVA in three provinces.

Waitlist Available
Has No Placebo

Arthritis Research Canada (+5 Sites)

Lora Giangregorio, PhD

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Injury Prevention Care Models for Osteoporosis

65+
All Sexes
Boston, MA

The goal of this clinical trial is to compare three care models for optimizing medications and preventing falls with broken bones in patients receiving rehabilitation after a hospitalization for a broken bone. The primary outcome is injurious falls, with secondary outcomes measuring how the process of care is changed and capturing patient-reported outcomes valued by stakeholders. The main questions this study aims to answer are: * Which of the three models is more effective in preventing falls with fractures? * What are the differences in patient-centered outcomes amongst the three models? These include pain, depression, anxiety, sleep, medication side effect burden, and fear of falling. * What are the differences in osteoporosis treatment and medication burden? The three care models are: a Deprescribing Care Model designed to reduce or stop fall-related medications, a Bone Heath Service Model designed to provide osteoporosis evaluation and management, and an Injury Prevention Service Model offering both services. 42 SNFs will participate in this study. The three models will be incorporated into the routine care of patients at these facilities who are receiving rehabilitation after a hospitalization for a fracture. All care models will be delivered remotely to patients in the SNF and after they transition home by a post-fracture nurse consultant supported by an interprofessional team. This study has three aims. See Detailed Description for more details. This ClinicalTrials.gov record represents the Comparative Effectiveness Aim of the protocol.

Waitlist Available
Has No Placebo

Marcus Institute for Aging Research, Hebrew SeniorLife (+1 Sites)

Cathleen S Colon-Emeric, MD, MHS

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